IMPORTANCE One-quarter of US women who are at risk for cervical cancer delay screening. Self-collected (SC) cervical screening was recently US Food and Drug Administration (FDA)-approved in the US for use in a health care setting only; an at-home SC option is crucial to address clinic-related barriers to screening. OBJECTIVE To clinically validate the use of an SC device that was designed for optimal at-home performance, safety, ease-of-use, and dry storage and transport. DESIGN, SETTING, AND PARTICIPANTS This nonrandomized clinical trial used a prospective method comparison study design. Participants aged 25 to 65 years were recruited from 16 clinical sites in the US including community and academic practices from November 20, 2023, to April 5, 2024. Data analysis was conducted from April to August 2024. INTERVENTION Eligible participants collected a sample with the SC method, followed by a clinician-collected (CC) sample. The SC sample was eluted into PreservCyt at the laboratory and both samples were tested on an FDA-approved high risk human papillomavirus (hrHPV) test approved for primary screening. Participants were followed up for safety and completed usability and screening preference surveys. MAIN OUTCOME AND MEASURES The primary outcome measures were positive percentage agreement (PPA) and negative percentage agreement for detection of hrHPV between the SC and CC samples. Other study measures included clinical sensitivity for high grade cervical dysplasia and usability. RESULTS Of 609 screening-eligible participants, 599 (262 aged 30-39 years [43.7%]; 583 identified as female [97.3%]) had paired SC-CC samples, of which 582 had valid paired samples included in the end point analysis. Among the 582 evaluable paired samples, the PPA between SC compared with paired CC samples for detection of hrHPV was 95.2% (95% CI, 92.1%-97.1%; 278 of 292 participants). The absolute clinical sensitivity for detection of high-grade cervical dysplasia was 95.8% (95% CI, 86.0%-98.8%; 46 of 48 participants), equivalent to the CC (relative sensitivity, 1.00). Nearly all participants (555 of 601 participants [92.3%]) reported that the device instructions were easy or very easy to understand and also that they would choose SC if they knew the results were comparable to CC results (560 of 602 participants [93.0%]). CONCLUSIONS AND RELEVANCE In this nonrandomized clinical trial, SC samples collected with the device showed equivalent clinical sensitivity and exceeded the PPA end point for cervical screening. This SC method was found to be easy to use and to be a preferred option with high clinical performance intended for use in an at-home setting.

One-quarter of US women who are at risk for cervical cancer delay screening. Self-collected (SC) cervical screening was recently US Food and Drug Administration (FDA)–approved in the US for use in a health care setting only; an at-home SC option is crucial to address clinic-related barriers to screening. To clinically validate the use of an SC device that was designed for optimal at-home performance, safety, ease-of-use, and dry storage and transport. This nonrandomized clinical trial used a prospective method comparison study design. Participants aged 25 to 65 years were recruited from 16 clinical sites in the US including community and academic practices from November 20, 2023, to April 5, 2024. Data analysis was conducted from April to August 2024. Eligible participants collected a sample with the SC method, followed by a clinician-collected (CC) sample. The SC sample was eluted into PreservCyt at the laboratory and both samples were tested on an FDA-approved high risk human papillomavirus (hrHPV) test approved for primary screening. Participants were followed up for safety and completed usability and screening preference surveys. The primary outcome measures were positive percentage agreement (PPA) and negative percentage agreement for detection of hrHPV between the SC and CC samples. Other study measures included clinical sensitivity for high grade cervical dysplasia and usability. Of 609 screening-eligible participants, 599 (262 aged 30-39 years [43.7%]; 583 identified as female [97.3%]) had paired SC-CC samples, of which 582 had valid paired samples included in the end point analysis. Among the 582 evaluable paired samples, the PPA between SC compared with paired CC samples for detection of hrHPV was 95.2% (95% CI, 92.1%-97.1%; 278 of 292 participants). The absolute clinical sensitivity for detection of high-grade cervical dysplasia was 95.8% (95% CI, 86.0%-98.8%; 46 of 48 participants), equivalent to the CC (relative sensitivity, 1.00). Nearly all participants (555 of 601 participants [92.3%]) reported that the device instructions were easy or very easy to understand and also that they would choose SC if they knew the results were comparable to CC results (560 of 602 participants [93.0%]). In this nonrandomized clinical trial, SC samples collected with the device showed equivalent clinical sensitivity and exceeded the PPA end point for cervical screening. This SC method was found to be easy to use and to be a preferred option with high clinical performance intended for use in an at-home setting. ClinicalTrials.gov Identifier: NCT06120205

Colposcopy is an office-based procedure performed to identify precancerous or cancerous lesions of the cervix. In 2017, colposcopy guidelines were developed by the American Society for Colposcopy and Cervical Pathology to standardize terminology, protocolize the procedure, and propose quality metrics. As a result of changes in cervical cancer screening and management guidelines, the volume of colposcopy within the United States has significantly decreased over the past 3 decades, and with the adoption of the human papillomavirus vaccination is anticipated to continue to decline. Therefore, colposcopic quality assessment and improved provider training is of increasing importance.

BACKGROUND AND IMPORTANCE:Untreated obturator nerve injury may result in weakness in thigh adduction, decreased medial thigh sensation, and groin pain. A neurosurgeon may be consulted intraoperatively for repair. Although there are reports of obturator nerve injury and repair in the gynecologic surgery literature, there are few reports detailing the specific steps of nerve repair after partial transection and the underlying principles of nerve coaptation, especially in the robotic-assisted setting. CLINICAL PRESENTATION:A partial transection of the right obturator nerve was noted in a patient undergoing total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and lymph node dissection using the da Vinci robot. Sutures were placed in the epineurium of the cut nerves to realign the fascicles. A porcine wrap was placed around the coaptation site and covered with fibrin glue. The right lower extremity was passively ranged to ensure no tension was present across the repair site. The patient had loss of right leg adduction after surgery, but she recovered full motor function 5 months after surgery with no numbness or pain. CONCLUSION:The current report describes a repair strategy for partial-thickness obturator nerve injury in the setting of a laparoscopic surgery. Working in a multidisciplinary fashion, the tenets of nerve repair may be applied to robotic-assisted cases of obturator nerve injury, resulting in neurologic recovery.

The American Society for Colposcopy and Cervical Pathology (ASCCP) provides practice guidance for clinicians caring for patients with lower genital tract conditions. The ASCCP wants to ensure that its library of guidance documents is current, evidence based, and easy for clinicians to use. Guidance documents should present clear, actionable evidence-based management recommendations where the quality of the evidence and the strength of the recommendation are clearly identified. This document explains ASCCP's new standard document types and the processes for their development and maintenance, as well as the process for selecting new topics.

Background: The HPV-automated visual evaluation (PAVE) Study is an extensive, multinational initiative designed to advance cervical cancer prevention in resource-constrained regions. Cervical cancer disproportionally affects regions with limited access to preventive measures. PAVE aims to assess a novel screening-triage-treatment strategy integrating self-sampled HPV testing, deep-learning-based automated visual evaluation (AVE), and targeted therapies. Methods: Phase 1 efficacy involves screening up to 100,000 women aged 25–49 across nine countries, using self-collected vaginal samples for hierarchical HPV evaluation: HPV16, else HPV18/45, else HPV31/33/35/52/58, else HPV39/51/56/59/68 else negative. HPV-positive individuals undergo further evaluation, including pelvic exams, cervical imaging, and biopsies. AVE algorithms analyze images, assigning risk scores for precancer, validated against histologic high-grade precancer. Phase 1, however, does not integrate AVE results into patient management, contrasting them with local standard care. Phase 2 effectiveness focuses on deploying AVE software and HPV genotype data in real-time clinical decision-making, evaluating feasibility, acceptability, cost-effectiveness, and health communication of the PAVE strategy in practice. Results: Currently, sites have commenced fieldwork, and conclusive results are pending. Conclusions: The study aspires to validate a screen-triage-treat protocol utilizing innovative biomarkers to deliver an accurate, feasible, and cost-effective strategy for cervical cancer prevention in resource-limited areas. Should the study validate PAVE, its broader implementation could be recommended, potentially expanding cervical cancer prevention worldwide. Funding: The consortial sites are responsible for their own study costs. Research equipment and supplies, and the NCI-affiliated staff are funded by the National Cancer Institute Intramural Research Program including supplemental funding from the Cancer Cures Moonshot Initiative. No commercial support was obtained. Brian Befano was supported by NCI/ NIH under Grant T32CA09168.

Cervical cancer screening and management in the U.S. has adopted a risk-based approach. However, the majority of cervical cancer cases and deaths occur in resource-limited settings, where screening and management are not widely available. We describe a conceptual model that optimizes cervical cancer screening and management in resource-limited settings by utilizing a risk-based approach. The principles of risk-based screening and management in resource limited settings include (1) ensure that the screening method effectively separates low-risk from high-risk patients; (2) directing resources to populations at the highest cancer risk; (3) screen using HPV testing via self-sampling; (4) utilize HPV genotyping to improve risk stratification and better determine who will benefit from treatment, and (5) automated visual evaluation with artificial intelligence may further improve risk stratification. Risk-based screening and management in resource limited settings can optimize prevention by focusing triage and treatment resources on the highest risk patients while minimizing interventions in lower risk patients.

ObjectiveColposcopy is an important part of cervical screening/management programs. Colposcopic appearance is often classified, for teaching and telemedicine, based on static images that do not reveal the dynamics of acetowhitening. We compared the accuracy and reproducibility of colposcopic impression based on a single image at one minute after application of acetic acid versus a time-series of 17 sequential images over two minutes.MethodsApproximately 5000 colposcopic examinations conducted with the DYSIS colposcopic system were divided into 10 random sets, each assigned to a separate expert colposcopist. Colposcopists first classified single two-dimensional images at one minute and then a time-series of 17 sequential images as ‘normal,’ ‘indeterminate,’ ‘high grade,’ or ‘cancer’. Ratings were compared to histologic diagnoses. Additionally, 5 colposcopists reviewed a subset of 200 single images and 200 time series to estimate intra- and inter-rater reliability.ResultsOf 4640 patients with adequate images, only 24.4% were correctly categorized by single image visual assessment (11% of 64 cancers; 31% of 605 CIN3; 22.4% of 558 CIN2; 23.9% of 3412 < CIN2). Individual colposcopist accuracy was low; Youden indices (sensitivity plus specificity minus one) ranged from 0.07 to 0.24. Use of the time-series increased the proportion of images classified as normal, regardless of histology. Intra-rater reliability was substantial (weighted kappa = 0.64); inter-rater reliability was fair ( weighted kappa = 0.26).ConclusionSubstantial variation exists in visual assessment of colposcopic images, even when a 17-image time series showing the two-minute process of acetowhitening is presented. We are currently evaluating whether deep-learning image evaluation can assist classification.

Isothermal amplification-based tests have been introduced as rapid, low-cost, and simple alternatives to real-time reverse transcriptase PCR (RT-PCR) tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection. The clinical performance of two isothermal amplification-based tests (Atila Biosystems iAMP coronavirus disease of 2019 [COVID-19] detection test and OptiGene COVID-19 direct plus RT-loop-mediated isothermal amplification [LAMP] test) was compared with that of clinical RT-PCR assays using different sampling strategies. A total of 1,378 participants were tested across 4 study sites. Compared with standard of care RT-PCR testing, the overall sensitivity and specificity of the Atila iAMP test for detection of SARS-CoV-2 were 76.2% and 94.9%, respectively, and increased to 88.8% and 89.5%, respectively, after exclusion of an outlier study site. Sensitivity varied based on the anatomic site from which the sample was collected. Sensitivity for nasopharyngeal sampling was 65.4% (range across study sites, 52.8% to 79.8%), for midturbinate was 88.2%, for saliva was 55.1% (range across study sites, 42.9% to 77.8%), and for anterior nares was 66.7% (range across study sites, 63.6% to 76.5%). The specificity for these anatomic collection sites ranged from 96.7% to 100%. Sensitivity improved in symptomatic patients (overall, 82.7%) and those with a higher viral load (overall, 92.4% for cycle threshold [CT] of ≤25). Sensitivity and specificity of the OptiGene direct plus RT-LAMP test, which was conducted at a single study site, were 25.5% and 100%, respectively. The Atila iAMP COVID test with midturbinate sampling is a rapid, low-cost assay for detecting SARS-CoV-2, especially in symptomatic patients and those with a high viral load, and could be used to reduce the risk of SARS-CoV-2 transmission in clinical settings. Variation of performance between study sites highlights the need for site-specific clinical validation of these assays before clinical adoption. IMPORTANCE Numerous SARS-CoV-2 detection assays have been developed and introduced into the market under emergency use authorizations (EUAs). EUAs are granted primarily based on small studies of analytic sensitivity and specificity with limited clinical validations. A thorough clinical performance evaluation of SARS-CoV-2 assays is important to understand the strengths, limitations, and specific applications of these assays. In this first large-scale multicentric study, we evaluated the clinical performance and operational characteristics of two isothermal amplification-based SARS-CoV-2 tests, namely, (i) iAMP COVID-19 detection test (Atila BioSystems, USA) and (ii) COVID-19 direct plus RT-LAMP test (OptiGene Ltd., UK), compared with those of clinical RT-PCR tests using different sampling strategies (i.e., nasopharyngeal, self-sampled anterior nares, self-sampled midturbinate, and saliva). An important specific use for these isothermal amplification-based, rapid, low-cost, and easy-to-perform SARS-CoV-2 assays is to allow for a safer return to preventive clinical encounters, such as cancer screening, particularly in low- and middle-income countries that have low SARS-CoV-2 vaccination rates.

The World Health Organization global call to eliminate cervical cancer encourages countries to consider introducing or improving cervical cancer screening programs. Brazil's Unified Health System (SUS) is among the world's largest public health systems offering free cytology testing, follow-up colposcopy, and treatment. Yet, health care networks across the country have unequal infrastructure, human resources, equipment, and supplies resulting in uneven program performance and large disparities in cervical cancer incidence and mortality. An effective screening program needs multiple strategies feasible for each community's reality, facilitating coverage and follow-up adherence. Prioritizing those at highest risk with tests that better stratify risk will limit inefficiencies, improving program impact across different resource settings. Highly sensitive human papillomavirus (HPV)-DNA testing performs better than cytology and, with self-collection closer to homes and workplaces, improves access, even in remote regions. Molecular triage strategies like HPV genotyping can identify from the same self-collected sample, those at highest risk requiring follow-up. If proven acceptable, affordable, cost-effective, and efficient in the Brazilian context, these strategies would increase coverage while removing the need for speculum exams for routine screening and reducing follow-up visits. SUS could implement a nationwide organized program that accommodates heterogenous settings across Brazil, informing a variety of screening programs worldwide.

•Public health education with media campaigns centered around HPV health risks and vaccine safety •Public health funding allowing widespread access for all adolescents and young adults •Education and incentives for primary healthcare providers to vaccinate •HPV vaccine mandates or school-based vaccination

OBJECTIVES:There are limited methods to identify which obese patients will experience wound complications after undergoing gynecologic surgery. We sought to determine the association between frailty and postoperative wound complications and to develop a prediction model for wound complications in this patient population.METHODS:We reviewed prospectively collected data of obese patients undergoing laparotomy though midline vertical incisions from 7/2013-3/2016. Modified frailty index (mFI) was calculated using 11 comorbidities previously validated. The primary outcome was the composite rate of postoperative wound complication. Data was analyzed using Fisher exact test or Chi-square and t-tests or Kruskal-Wallis tests. Poisson regression models were used to generate relative risks. Prediction models were created with receiver-operator characteristic curve analysis.RESULTS:Of 163 patients included, 56 (34%) were considered frail. Wound complications occurred in 52 patients (31.9%): 28 (50%) frail and 24 (22.4%) non-frail patients (RR 2.23, 95%CI 1.29-3.85). Frail patients had significantly greater frequencies of wound breakdown (37.5% vs 15%, RR 2.51, 95%CI 1.31-4.81). After controlling for BMI, tobacco use, and maximum postoperative glucose, frailty remained an independent predictor of wound complication (aRR 1.88, 95%CI 1.04-3.40). The area under the curve for the predictive model incorporating frailty was 0.73 for wound complications.CONCLUSION:Frailty is associated with wound complications in obese patients undergoing gynecologic surgery via a midline vertical incision and is a useful tool in identifying the most high risk patients. Further prospective research is necessary to incorporate mFI into preoperative planning and counseling.

We examined whether automated visual evaluation (AVE), a deep learning computer application for cervical cancer screening, can be used on cervix images taken by a contemporary smartphone camera. A large number of cervix images acquired by the commercial MobileODT EVA system were filtered for acceptable visual quality and then 7587 filtered images from 3221 women were annotated by a group of gynecologic oncologists (so the gold standard is an expert impression, not histopathology). We tested and analyzed on multiple random splits of the images using two deep learning, object detection networks. For all the receiver operating characteristics curves, the area under the curve values for the discrimination of the most likely precancer cases from least likely cases (most likely controls) were above 0.90. These results showed that AVE can classify cervix images with confidence scores that are strongly associated with expert evaluations of severity for the same images. The results on a small subset of images that have histopathologic diagnoses further supported the capability of AVE for predicting cervical precancer. We examined the associations of AVE severity score with gynecologic oncologist impression at all regions where we had a sufficient number of cases and controls, and the influence of a woman's age. The method was found generally resilient to regional variation in the appearance of the cervix. This work suggests that using AVE on smartphones could be a useful adjunct to health-worker visual assessment with acetic acid, a cervical cancer screening method commonly used in low- and middle-resource settings.

Background Accelerated global control of cervical cancer would require primary prevention with human papillomavirus (HPV) vaccination in addition to novel screening program strategies that are simple, inexpensive, and effective. We present the feasibility and outcome of a community-based HPV self-sampled screening program. Methods In Ile Ife, Nigeria, 9406 women aged 30–49 years collected vaginal self-samples, which were tested for HPV in the local study laboratory using Hybrid Capture-2 (HC2) (Qiagen). HPV-positive women were referred to the colposcopy clinic. Gynecologist colposcopic impression dictated immediate management; biopsies were taken when definite acetowhitening was present to produce a histopathologic reference standard of precancer (and to determine final clinical management). Retrospective linkage to the medical records identified 442 of 9406 women living with HIV (WLWH). Results With self-sampling, it was possible to screen more than 100 women per day per clinic. Following an audio-visual presentation and in-person instructions, overall acceptability of self-sampling was very high (81.2% women preferring self-sampling over clinician collection). HPV positivity was found in 17.3% of women. Intensive follow-up contributed to 85.9% attendance at the colposcopy clinic. Of those referred, 8.2% were initially treated with thermal ablation and 5.6% with large loop excision of transformation zone (LLETZ). Full visibility of the squamocolumnar junction, necessary for optimal visual triage and ablation, declined from 68.5% at age 30 to 35.4% at age 49. CIN2+ and CIN3+ (CIN- Cervical intraepithelial neoplasia), including five cancers, were identified by histology in 5.9 and 3.2% of the HPV-positive women, respectively (0.9 and 0.5% of the total screening population), leading to additional treatment as indicated. The prevalences of HPV infection and CIN2+ were substantially higher (40.5 and 2.5%, respectively) among WLWH. Colposcopic impression led to over- and under-treatment compared to the histopathology reference standard. Conclusion A cervical cancer screening program using self-sampled HPV testing, with colposcopic immediate management of women positive for HPV, proved feasible in Nigeria. Based on the collected specimens and images, we are now evaluating the use of a combination of partial HPV typing and automated visual evaluation (AVE) of cervical images to improve the accuracy of the screening program.

Background. The risk factors for extended length of stay (LOS) have not been examined in a cohort of patients with complex social and medical barriers who undergo robotic assisted (RA) surgery for gynecologic malignancies. We sought to identify those patients with a LOS > 24 h after robotic surgery and the risk factors associated with delayed discharge. Then we aimed to develop a predictive model for clinical care and identify modifiable pre-operative risk factors. Methods. After IRB approval, data was abstracted from medical records of all patients with a gynecologic malignancy who underwent a RA laparoscopic surgery from 2010 to 2015. Univariable and multivariable logistic regression was performed to identify independent risk factors associated with delayed discharge defined as LOS > 24 h. A multi-variable logistic regression model was performed using a stepwise backward selection for the final prediction model. All testing was two-sided and a p-value < 0.05 was considered statistically significant. Results. Of the 406 eligible and evaluable patients, 194 (48%) had a LOS > 24 h. Age >= 60 years, a higher usage of narcotic medication, a longer surgical time, and a larger estimated blood loss were all associated with LOS > 24 h (p < 0.05). Many of these women had a social work consultation and went home with home care services despite no surgical or post-operative complications. Our prediction model has the potential to correctly classified 75% of the patients discharged within 24 h. Conclusions. The development of a pre-hospitalization risk stratification and anticipating the possible need for home care services pre-operatively shows promise as a strategy to decrease LOS in patients classified as high-risk. These findings warrant prospective validation through the use of this prediction model in our institution. Published by Elsevier Inc.

OBJECTIVE:The Patient-Reported Outcomes Measurement Information System (PROMIS®) Network has developed a comprehensive repository of electronic patient reported outcomes measures (ePROs) of major symptom domains that have been validated in cancer patients. Their use for patients with gynecologic cancer has been understudied. Our objective was to establish feasibility and acceptability of PROMIS ePRO integration in a gynecologic oncology outpatient clinic and assess if it can help identify severely symptomatic patients and increase referral to supportive services.METHODS:English-speaking patients with a confirmed history of gynecologic cancer completed PROMIS ePROs on iPads in the waiting area of an outpatient gynecologic oncology clinic. Symptom scores were calculated for each respondent and grouped using documented severity thresholds. Response data was compared with clinicopathologic characteristics across symptom domains. Severely symptomatic patients were offered referral to ancillary services and asked to complete post-exposure surveys assessing acceptability of the ePRO.RESULTS:Of the 336 patients who completed ePROs, 35% had active disease and 19% had experienced at least one disease recurrence. Sixty-nine percent of the cohort demonstrated moderate to severe physical dysfunction (60%), pain (36%), fatigue (28%), anxiety (9%), depression (8%), and sexual dysfunction (32%). Thirty-nine (12%) severely symptomatic patients were referred to services such as psychiatry, palliative care, pain management, social work or integrative oncology care. Most survey respondents identified the ePROs as helpful (78%) and easy to complete (92%).CONCLUSIONS:Outpatient PROMIS ePRO administration is feasible and acceptable to gynecologic oncology patients and can help identify severely symptomatic patients for referral to ancillary support services.

Jenna Z. Marcus, MD Dr. Marcus is Assistant Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey. Akiva P. Novetsky, MD, MS Dr. Novetsky is Associate Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey, and Chief Quality Officer, Rutgers Cancer Institute of New Jersey, New Brunswick. Mark H. Einstein, MD, MS Dr. Einstein is Professor and Chair, Department of Obstetrics, Gynecology and Women’s Health, and Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical School, Newark, New Jersey.

Background: Venous thromboembolism after open gynecologic surgery is not uncommon, especially in the presence of other risk factors such as obesity, prolonged surgical time or gynecologic malignancy. Case: We present the case of a 62 y.o. patient who underwent open hysterectomy and surgical staging for uterine serous carcinoma. She was readmitted with lower extremity edema. During her workup, she underwent cardiovascular arrest secondary to saddle pulmonary embolus requiring cardiopulmonary resuscitation and extracorporeal membrane oxygenation. After systemic and catheter directed thrombolysis, and a long hospitalization, she was discharged home in stable condition. Conclusion: Saddle pulmonary embolus is a potentially catastrophic and fatal postoperative complication. This case demonstrates a successful implementation of directed thrombolysis, veno-arterial extracorporeal membrane oxygenation and multidisciplinary management in a case of postoperative saddle pulmonary embolus. Precis: We report a case of an endometrial cancer patient who sustained a massive postoperative pulmonary embolus and was successfully resuscitated using extracorporeal membrane oxygenation.

Objective: Diagnosis of endometrial clear cell carcinomas is difficult owing to the low reproducibility of histological cell type in high-grade endometrial cancers. Recently, immunoreactivity for napsin A and glypican 3 has been reported in clear cell cancers. We sought to evaluate the use of nap sin A and glypican 3 staining to distinguish clear cell carcinoma from other high-grade endometrial cancers. Methods/Materials: Twenty cases of pure and mixed endometrial clear cell carcinoma were extracted from the 2000-2014 archival material in the Departments of Obstetrics & Gynecology and Pathology at Montefiore Medical Center and compared to serous and grade 3 endometrioid controls. Representative sections were stained with monoclonal antibodies to napsin A and glypican 3. Immunostains were independently reviewed by 2 pathologists to assess frequency and pattern of staining. Charts were reviewed for clinicopathologic and treatment data. Results: Granular cytoplasmic positivity for napsin A was observed in 70% of endometrial clear cell carcinomas; only 25% showed cytoplasmic or membranous glypican 3 positivity. No serous or high-grade endometrioid tumors stained for either marker. No cases of clear cell carcinoma that stained negative for napsin A stained positive for glypican 3. No difference in the immunohistochemical profile was found between pure and mixed clear cell carcinomas and between early- and advanced-stage clear cell carcinomas. Conclusions: Napsin A is a more sensitive marker for endometrial clear cell carcinoma than glypican 3. In histologically ambiguous cases, napsin A and glypican 3 may help distinguish clear cell carcinoma from other high-grade histologies. Further investigation of endometrial clear cell carcinoma is needed to identify additional diagnostic tools for this rare histology. Correlation of a unique immunohistochemical profile and clinical outcomes is necessary.

Objective: To assess the prevalence of venous thromboembolism (VTE) in patients with uterine serous carcinoma and identify risk factors for VTE in this patient population.