Background In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results A simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided. Conclusions This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.

Department of Medicine, Digestive Oncology Unit, Medical Oncology, Institut Jules Bordet, ULB, Brussels, Belgium Correspondence to Alain Hendlisz, Department of Medicine, Digestive Oncology Unit, Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. Tel: +32 2 541 31 96; fax: +32 2 538 08 58; e-mail: [email protected]

OBJECTIVETo examine changes in colorectal cancer mortality in 34 European countries between 1970 and 2011.DESIGNRetrospective trend analysis.DATA SOURCEWorld Health Organization mortality database.POPULATIONDeaths from colorectal cancer between 1970 and 2011. Profound changes in screening and treatment efficiency took place after 1988; therefore, particular attention was paid to the evolution of colorectal cancer mortality in the subsequent period.MAIN OUTCOMES MEASURESTime trends in rates of colorectal cancer mortality, using joinpoint regression analysis. Rates were age adjusted using the standard European population.RESULTSFrom 1989 to 2011, colorectal cancer mortality increased by a median of 6.0% for men and decreased by a median of 14.7% for women in the 34 European countries. Reductions in colorectal cancer mortality of more than 25% in men and 30% in women occurred in Austria, Switzerland, Germany, the United Kingdom, Belgium, the Czech Republic, Luxembourg, and Ireland. By contrast, mortality rates fell by less than 17% in the Netherlands and Sweden for both sexes. Over the same period, smaller or no declines occurred in most central European countries. Substantial mortality increases occurred in Croatia, the former Yugoslav republic of Macedonia, and Romania for both sexes and in most eastern European countries for men. In countries with decreasing mortality, reductions were more important for women of all ages and men younger than 65 years. In the 27 European Union member states, colorectal cancer mortality fell by 13.0% in men and 27.0% in women, compared with corresponding reductions of 39.8% and 38.8% in the United States.CONCLUSIONOver the past 40 years, there has been considerable disparity in the level of colorectal cancer mortality between European countries, as well as between men and women and age categories. Countries with the largest reductions in colorectal cancer mortality are characterised by better accessibility to screening services, especially endoscopic screening, and specialised care.

Abstract Background: Randomized trials have shown that fecal-occult-blood-test (FOBT) and endoscopic exterminations of the large bowel were able to decrease the risk of CRC death. We examined whether changes in CRC mortality in Europe were associated with a history of screening. Methods: We used data collected as part of the Survey of Health, Aging, and Retirement in Europe (SHARE) project to extract information on exposure to CRC screening in subjects 50 years old or more living in 11 European countries. Distinct data were collected for endoscopy (colonoscopy or sigmoidoscopy) and FOBT. Using the WHO mortality database on causes of deaths, we fitted linear regressions from 1989 to 2010 and calculated changes in mortality for men and women living in each of the 11 countries. We used least square regression and computed R-square statistics (expressed in %) to provide estimates of the association between screening history and changes in CRC mortality. Results: Over the 22-year period, changes in age-adjusted CRC mortality rates among males/females were -39/-47% in Austria, -34/-32% in France, -30/-44% in Germany, -26/-35% in Switzerland, -17/-23% in Italy, -14/-18% in Denmark, -10/-8% in Sweden, -4/-10% in the Netherlands, +29/-6% in Spain, and +30/+2% in Greece. In males, reports of ever having had an endoscopic examination of the large bowel ranged from 8% in Greece to 35% in Austria. For females, proportions of ever having undergone endoscopic examinations ranged from 8% in Greece to 36% in Austria. FOBT screening over the last 10 years, ranged from 4% in the Netherlands to 61% in Austria for both sexes. In males, a history of one or more endoscopic examination of the large bowel explained 73% of the decrease in CRC mortality. Having had at least one endoscopy or FOBT over the past 10 years explained 54 and 53% of the observed decrease in CRC mortality, respectively. In females, a history of one or more endoscopic examination of the large bowel explained 82% of the decrease in CRC mortality. Having had at least one endoscopy or FOBT over the past 10 years explained 89 and 72% of the decrease, respectively. All R-squares had an associated p value < 0.001. Conclusions: Changes in CRC mortality are correlated with the level of screening uptake. This provides “real world” evidence of the effectiveness of screening to prevent CRC mortality in the general population and a strong rational for current national CRC screening programs. Citation Format: Driss Ouakrim, Eva Negri, Matteo Malvezzi, Harry Bleiberg, Mark Jenkins, Mathieu Boniol, Philippe Autier. Trends in colorectal cancer mortality and screening activities in European countries. [abstract]. In: Proceedings of the Twelfth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2013 Oct 27-30; National Harbor, MD. Philadelphia (PA): AACR; Can Prev Res 2013;6(11 Suppl): Abstract nr C09.

The traditional endpoint for assessing efficacy of chemotherapies for advanced/recurrent gastric cancer is overall survival (OS), but OS requires prolonged follow-up. We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC meta-analysis, surrogacy of PFS was assessed through the correlation between the endpoints and through the correlation between the treatment effects on the endpoints. External validation of the prediction based on PFS was also evaluated. Individual data from 4069 patients in 20 randomized trials were analyzed. The rank correlation coefficient between PFS and OS was 0.853 (95% confidence interval [CI] = 0.852 to 0.854). The R-2 between treatment effects on PFS and on OS was 0.61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer.

In investigations of the effectiveness of surgery and adjuvant chemotherapy for gastric cancers, overall survival (OS) is considered the gold standard endpoint. However, the disadvantage of using OS as the endpoint is that it requires an extended follow-up period. We sought to investigate whether disease-free survival (DFS) is a valid surrogate for OS in trials of adjuvant chemotherapy for gastric cancer.The GASTRIC group initiated a meta-analysis of individual patient data collected in randomized clinical trials comparing adjuvant chemotherapy vs surgery alone for patients with curatively resected gastric cancer. Surrogacy of DFS was assessed through the correlation between the endpoints as well as through the correlation between the treatment effects on the endpoints. External validation of the prediction based on DFS was also evaluated.Individual patient data from 14 randomized clinical trials that included a total of 3288 patients were analyzed. The rank correlation coefficient between DFS and OS was 0.974 (95% confidence interval [CI] 0.971 to 0.976). The coefficient of determination between the treatment effects on DFS and on OS was as high as 0.964 (95% CI 0.926 to 1.000), and the surrogate threshold effect based on adjusted regression analysis was 0.92. In external validation, the six hazard ratios for OS predicted according to DFS were in very good agreement with those actually observed for OS.DFS is an acceptable surrogate for OS in trials of cytotoxic agents for gastric cancer in the adjuvant setting.

We conducted an individual-patient-data meta-analysis of the efficacy of chemotherapy on overall survival (OS) and progression-free survival (PFS) in advanced/recurrent gastric cancer (AGC). Our primary research question was whether the experimental arms of the trials included in the meta-analysis showed a benefit as compared with their corresponding control arms. MEDLINE (up to 2010), Cochrane Central Register of Controlled Trials, National Institutes of Health (NIH) trial registry and proceedings of major oncologic and gastrointestinal cancer meetings were searched. Randomised controlled trials for AGC closed to patient accrual before the end of 2006 were eligible. As of December 2010, individual patient data were available from 22 trials (4245 patients, representing 47% of the targeted data) of 55 eligible trials. The overall comparison of experimental arms with the corresponding control arms showed statistically significant differences in terms of both OS and PFS. Hazard ratio was 0.88 (95% confidence interval 0.82-0.94, P<0.0001) for OS and 0.81 (0.76-0.88, P<0.0001) for PFS. The results of the sub-analysis of adding a given chemotherapeutic agent to any chemotherapy confirm the results of the overall analysis, with a hazard reduction of 11% for OS (P<0.01) and 26% for PFS (P<0.0001). This meta-analysis of individual patient data shows that the additions of experimental chemotherapeutic agents to pre-existing control or standard regimens have produced a modest improvement in OS and PFS. Median survival remained below 1 year for all investigated chemotherapy regimens and none emerged as a clear standard.

BACKGROUND: Accurate preoperative assessment of adnexal masses permits appropriate triage of malignant tumours to gynaecological oncologists in cancer centres while allowing benign lesions to be managed by general gynaecologists. The Risk of Malignancy Index (RMI) is routinely used for triaging women with adnexal masses. OBJECTIVES: This paper evaluates the value of Ovarian HistoScanning, a novel computerised technique to interpret ultrasound data, in improving triage of women with adnexal masses. METHODS: RMI indices were assessed in 199 women enrolled in a prospective HistoScanning study. Ultrasound scores were obtained by blinded analysis of archived images. The following sequential test was developed: HistoScanning was modelled as a second-line test for RMI between a lower cut-off and an upper cut-off. The optimal combination of these cut-offs that together maximized the Youden index (Sensitivity + Specificity -1) was determined. RESULTS: Using RMI at the standard cut-off value of 250 resulted in a sensitivity of 74% and a specificity of 86%. When RMI was combined with HistoScanning, the highest accuracy was achieved by using HistoScanning as a sequential second-line test for patients with RMI values between 105 and 2100. At these cut-off values, sequential use of RMI and HistoScanning resulted in mean sensitivity and specificity estimates of 88% and 95%, respectively. CONCLUSIONS: Our data suggest that HistoScanning may have the potential to improve the diagnostic accuracy of RMI, which could result in a better triage of women with adnexal masses. Further prospective validation is warranted. Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.

BACKGROUND Leucovorin Sodium (LV/Na) has a high solubility, and is stable when given with continuous infusion of 5-FU. It could maintain significant plasma concentration of 5, 10-meTHF during the whole 5-FU perfusion with the potential of increasing 5-FU cytotoxicity. We conducted a randomized phase II clinical trial on leucovorin calcium (LV/Ca) and LV/Na in metastatic colorectal cancer patients (mCRC). Main objectives were to assess efficacy and safety. PATIENTS AND METHODS Fifty seven patients with mCRC and no previous chemotherapy for metastatic disease were randomized to receive LV/Na or LV/Ca with irinotecan or oxaliplatine combined with infusional 5-FU. LV/Na was defined as warranting further evaluation in phase III if true overall response rate (ORR) > 35% (α=5%, β=10% in case of true ORR >55%, 51 evaluable patients planned/arm). RESULTS Results for LV/Ca and LV/Na arm respectively were: observed ORR, 55% (significantly higher than 35%, p = 0.02) and 61% (p = 0.004). Median overall survival durations were 11.9 months and 22.9 months (p = 0.02) and PFS 8.0 vs. 11.5 months (ns). Grade 3 events were 64% and 46% (p = 0.28). CONCLUSION Both LV/Na and LV/Ca disclosed an ORR > 35% with comparable safety.

4109 Background: Advanced or recurrent stomach cancer remains an incurable disease and little progress has been obtained in prolonging survival. Multiple drugs and combinations of chemotherapy (CT) have been investigated with limited benefit on overall survival. The GASTRIC project initiated an individual-patient-data (IPD) based meta-analysis to quantify the benefit of various CTs. Methods: Randomized clinical trials (RCT) closed to patient accrual before 2004 were searched based on predefined criteria. The primary endpoint was overall survival (OS), the secondary progression-free-survival (PFS). The log-rank test, stratified by trial, was used to compare treatment arms; Peto heterogeneity tests were used. “Experimental” arms were defined as containing more drugs and/or a newer agent. We subsequently restricted analyses to trials that compared a CT with the same plus an additional compound. Eventually, we investigated comparisons of regimens including FUs, anthracyclines, platinums, taxanes, or irinotecan. Results: Fifty RCTs (N = 7,746) were identified, IPD (N = 4,245) was available from 22 studies. In the comparison of experimental with the control arms, highly significant differences were observed. Addition of a compound also showed a significant improvement in OS and PFS. There was no specific regimen which showed statistically significant differences on OS while platinums- and irinotecan-based regimens showed the statistically significant PFS improvements vs comparative arms. Conclusions: This IPD meta-analysis showed that OS and PFS have been modestly but significantly improved by the addition of experimental CT agents to preexisting control or standard regimens, but no specific regimen was identified as clearly superior. No. of trials Events/N HR (95% CI) P value Heterogeniety P Experimental Control OS 22 2,204/2,477 1,562/1,737 0.87 (0.81, 0.93) < 0.001 0.10 PFS 20 2,250/2,404 1,572/1,669 0.79 (0.68, 0.84) < 0.001 0.01 CT + additional CT OS 13 936/1,060 745/850 0.89 (0.81, 0.98) 0.02 0.72 PFS 13 946/1,022 751/815 0.74 (0.66, 0.81) < 0.001 0.11

Purpose: Accurate preoperative clinical assessment of adnexal masses can optimize outcomes by ensuring appropriate and timely surgery. This article addresses whether a new technology, ovarian HistoScanning, has an additional diagnostic value in mathematical models developed for the differential diagnosis of adnexal masses.Patients and Methods: Transvaginal sonography-based morphological variables were obtained through blinded analysis of archived images in 199 women enrolled in a prospective study to assess the performance of ovarian HistoScanning. Logistic regression (LR) and neural network (NN) models including these variables and clinical and patient data along with the HistoScanning score (HSS) (range, 0-125; based on mathematical algorithms) were developed in a learning set (60% patients). The remaining 40% patients (evaluation set) were used to assess model performance.Results: Of all morphological and clinical variables tested, serum CA-125, presence of a solid component, and HSS were most significant and used to develop the LR model. The NN model included all variables. The novel variable, HSS, offered significant improvement in the LR and NN models' performance. The LR and NN models in an independent evaluation set were found to have area under the receiver operating characteristic curve = 0.97 (95% confidence interval [CI], 94-99) and 0.93 (95% CI, 88-98), sensitivities = 83% (95% CI, 71%-91%) and 80% (95% CI, 67%-89%), and specificities = 98% (95% CI, 89%-99%) and 86% (95% CI, 72%-95%), respectively. In addition, these models showed an improved performance when compared with 3 other existing models (all P < 0.05).Conclusions: This initial report shows a clear benefit of including ovarian HistoScanning into mathematical models used for discriminating benign from malignant ovarian masses. These models may be specifically helpful to the less experienced examiner. Future research should assess performance of these models in prospective clinical trials in different populations.

e14019 Background: 5-FU modulated by leucovorin calcium (LVCa) remains the mainstay of therapy for CRC. It is expected that LV Sodium (LVNa), which is stable when given with continuous infusion (ci) of 5-FU, could further enhance its activity. Methods: Eligibility criteria include confirmed mCRC, unresectable metastases, no previous chemotherapy, age ≥ 18 years, WHO-PS: ≤2. Pts received irinotecan 180 mg/m2 IV/30-90 min or oxaliplatin 100 mg/m2 IV/120 min and were randomized for LVCa 400 mg/m2/2 hours, followed by 5-FU bolus 400 mg/m2, and by 5-FU 3,000 mg/m2 IV ci/46 hours or, LVNa 400 mg/m2 plus 5-FU 3,000 mg/m2, IV ci/46 hours. Primary endpoint was objective response rate (ORR) by investigators and independent panel and assessed on pts who had a baseline and at least one post-baseline evaluations. Main secondary endpoints included safety, and overall/progression-free survival (OS, PFS) based on all pts treated. Experimental treatment was defined as warranting further evaluation in phase III if true ORR > 35 %(α=5%, β=10% in case of true ORR > 55%, 51 evaluable patients planned/arm). Results: See Table. Conclusions: LVNa disclosed an ORR >35% (study positive according to planning despite reduced sample size) and induces no more toxicity than LVCa. OS in favor of LVNa triggers the concept of improved activity of 5-FU/LV with LVNa ci which needs to be further validated in a phase III study. ORR Treatment Group % ORR (CI) P for ORR>35%- LVCa Investigators 66 (46-42) 0.01 Independent review 50 (31-68) 0.062 LVNa Investigators 63 (44-78) <0.01 Independent review 59 (40-75) <0.01 Survival Parameter Treatment Median (CI) P for LVNa vs. LVCa OS (months) LVCa 11.93 (9,17-19.83) LVNa 22.90 (16,66—) 0.02 PFS (months) LVCa 8.02 (7.26-9.03) LVNa 11.5 (7.26-19.09) 0.1 Toxicity Adverse events Treatment No. (%) P for LVNa vs. LVCa No. grade 3-4 AE >2 LVCa 6 (21.4) LVNa 5 (17.8) ns % with 1 or > grade 3-4 AE LVCa 18 (64.2) LVNa 13 (46.4) ns Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sirtex SA, Taiho Pharmaceutical, Teva

Objectives To prospectively assess an innovative computer-aided diagnostic technology that quantifies characteristic features of backscattered ultrasound and theoretically allows transvaginal sonography (TVS) to discriminate benign from malignant adnexal masses. Methods Women ( n = 264) scheduled for surgical removal of at least one ovary in five centres were included. Preoperative three-dimensional (3D)-TVS was performed and the voxel data were analysed by the new technology. The findings at 3D-TVS, serum CA125 levels and the TVS-based diagnosis were compared with histology. Cancer was deemed present when invasive or borderline cancerous processes were observed histologically. Results Among 375 removed ovaries, 141 cancers (83 adenocarcinomas, 24 borderline, 16 cases of carcinomatosis, nine of metastases and nine others) and 234 non-cancerous ovaries (107 normal, 127 benign tumours) were histologically diagnosed. The new computer-aided technology correctly identified 138/141 malignant lesions and 206/234 non-malignant tissues (98% sensitivity, 88% specificity). There were no false-negative results among the 47 FIGO stage I/II ovarian lesions. Standard TVS and CA125 had sensitivities/specificities of 94%/66% and 89%/75%, respectively. Combining standard TVS and the new technology in parallel significantly improved TVS specificity from 66% to 92% ( p < 0.0001). Conclusions Computer-aided quantification of backscattered ultrasound is a highly sensitive for the diagnosis of malignant ovarian masses.

Primary signet-ring cell carcinoma (SRCC) of vermiform appendix is extremely rare; only three cases have been reported in the English literature. An 89-year-old man suddenly presented right lower abdominal pain, and transferred to a hospital, where he was diagnosed with acute appendicitis by physical data, blood data, and CT. He was further transferred to our hospital for emergency operation. Physical examination showed positive abdominal pain, Blunberg sign, and Rosenstein sign. Blood test showed leukocytosis and increased C-reactive protein. An appendectomy was performed. Gross examination during operation showed inflamed appendix, appendiceal adhesion, and acute peritonitis. Gross pathological examination showed no apparent tumor, but the proximal appendix showed wall thickening and luminal occlusion. The appendix was cut into three sections, and was observed under microscopically. Nests of carcinoma cells were seen in the proximal appendix. The carcinoma was composed of SRCC (70%) and mucinous carcinoma (30%). The size of carcinoma was 6 × 7 mm. The carcinoma cells invaded into muscular layer. No lymphovascular permeation was seen. The cut margins were negative for carcinoma cells. Immunohistochemically, SRCC cells were positive for cytokeratin (CK) AE1/3, CK CAM5.2, CK8, CK18, CK19, CK20, EMA, CEA, CA19-9, p53, Ki-67 (labeling = 30%), CDX2, MUC2, and MUC5AC. They were negative for CK34PE1, CK5/6, CK7, CK14, p63, vimentin, TTF-1, MUC1, MUC 5AC, NSE, synaptophysin, chromogranin, and CD56. No further treatments were performed, because the appendiceal carcinoma was small, the surgical margins were negative and the patient was very old. He was followed up by various imaging modalities. No recurrence or metastasis is found 17 months after the operation.

Following endocrine therapy, progression to a hormone-refractory state is inevitable in patients with locally advanced or metastatic prostate cancer, if they survive competing mortality. Current treatment options are essentially palliative, with the aim of maintaining quality of life and prolonging survival.Following the failure of primary androgen ablation, a number of treatment strategies are available. Exploitation of the anti-androgen withdrawal syndrome and further hormonal therapies are well-established treatments. More recently, interest in chemotherapy has been renewed owing to demonstrable benefits in prostate specific antigen (PSA) response and pain palliation, albeit without any improvements in survival.However, future treatment options that can prolong survival and maintain quality of life for patients with hormone-refractory prostate cancer (HRPC) are constantly being sought. An increased understanding of the molecular biology of prostate cancer has led to the identification of novel targets and agents. The evaluation of these, and possible addition of them to our armamentarium against prostate cancer, is the goal of ongoing clinical trials.

PURPOSE:Adjuvant systemic chemotherapy administered after surgical resection of colorectal cancer metastases may reduce the risk of recurrence and improve survival, but its benefit has never been demonstrated. Two phase III trials (Fédération Francophone de Cancérologie Digestive [FFCD] Trial 9002 and the European Organisation for Research and Treatment of Cancer/National Cancer Institute of Canada Clinical Trials Group/Gruppo Italiano di Valutazione Interventi in Oncologia [ENG] trial) used a similar design and showed a trend favoring adjuvant chemotherapy, but both had to close prematurely because of slow accrual, thus lacking the statistical power to demonstrate the predefined difference in survival. We report here a pooled analysis based on individual data from these two trials. PATIENTS AND METHODS:After complete resection of colorectal liver or lung metastases, patients were randomly assigned to chemotherapy (CT arm; fluorouracil [FU] 400 mg/m(2) administered intravenously [IV] once daily plus dl-leucovorin 200 mg/m(2) [FFCD] x 5 days or FU 370 mg/m(2) plus l-leucovorin 100 mg/m(2) IV x 5 days [ENG] for six cycles at 28-day intervals) or to surgery alone (S arm). RESULTS:A total of 278 patients (CT, n = 138; S, n = 140) were included in the pooled analysis. Median progression-free survival was 27.9 months in the CT arm as compared with 18.8 months in the S arm (hazard ratio = 1.32; 95% CI, 1.00 to 1.76; P = .058). Median overall survival was 62.2 months in the CT arm compared with 47.3 months in the S arm (hazard ratio = 1.32; 95% CI, 0.95 to 1.82; P = .095). Adjuvant chemotherapy was independently associated with both progression-free survival and overall survival in multivariable analysis. CONCLUSION:This pooled analysis shows a marginal statistical significance in favor of adjuvant chemotherapy with an FU bolus-based regimen after complete resection of colorectal cancer metastases.

OBJECTIVETo determine the extent to which computer‐aided ultrasonography of the prostate (HistoScanningTM, Advanced Medical Diagnostics, Waterloo, Belgium) can identify tumour foci that correspond to a volume of ≥0.50 mL.PATIENTS AND METHODSBetween September 2004 and February 2006, 29 men were HistoScanned before scheduled radical prostatectomy. The three‐dimensional raw (grey‐scaled) data required for HistoScanning analysis were acquired by transrectal ultrasonography, and analysed using organ‐specific tissue‐characterization algorithms which form the core of the HistoScanning technology. The HistoScanning analysis results were compared with the histology of the whole‐mounted prostate, step‐sectioned sagittally at 5‐mm intervals, and each slide analysed by 5 × 5 mm grid analysis.RESULTSOf 29 patients, 13 had histology unknown to those evaluating the HistoScanning data. With 0.50 mL as the lower threshold for delineating and visualizing cancer volume, HistoScanning correctly predicted the presence of all 12 lesions that were subsequently confirmed to occupy ≥0.50 mL. In addition three lesions were predicted as being present and of ≥0.50 mL. These three lesions were subsequently confirmed to be present but were ≤0.50 mL on histopathological review. Thus, using the clinically accepted volume threshold of 0.50 mL, the sensitivity, specificity, positive and negative predictive value of HistoScanning were 12/12, 13/16 (82%), 12/15 (80%) and 12/12, respectively, for the cancer foci analysed.CONCLUSIONSIn this preliminary study, HistoScanning accurately detected cancer foci of ≥0.50 mL; these encouraging results will need to be verified in a larger group of patients.