Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study.

Testicular cancer (TC) survivors have an increased risk of various second primary malignancies. A recent cohort study detected an increased risk of colorectal cancer (CRC) in TC survivors treated with platinum-based chemotherapy with a hazard ratio of 3. 9. CRC risk increased with higher cisplatin-dose. We know that colonoscopy surveillance in high-risk populations results in reduced incidence and mortality of CRC. TC survivors treated with platinum-based chemotherapy can potentially benefit from colonoscopy surveillance; however, to which extent is unknown. Furthermore, the pathogenesis of these secondary CRCs is unknown, and better insights into the carcinogenesis may affect surveillance decisions.

This prospective multicenter study will be performed in four Dutch hospitals. TC survivors are eligible if treated with ≥ 3 cycles of cisplatin before age 50. Colonoscopy will be performed ≥ 8 years after initial treatment (minimum and maximum ages at colonoscopy, 35 and 75 years, respectively). The primary aim of the study is the diagnostic yield of advanced neoplasia detected during colonoscopy. As secondary aim, we will evaluate the molecular profile of advanced colorectal neoplasia and will assess current platinum levels in blood and urine and correlate blood-platinum levels with prevalence of colorectal lesions. Furthermore, we will investigate effectiveness of fecal immunochemical testing (FIT) and burden of colonoscopy by two questionnaires. Demographic data, previous history, results of colonoscopy, hemoglobin level of FIT and results of molecular and platinum levels will be obtained. Yield of colonoscopy will be determined by detection rate of adenoma and serrated lesions, advanced adenoma detection rate and CRC detection rate. The MISCAN model will be used for cost-effectiveness analyses of CRC surveillance. With 234 participants undergoing colonoscopy, we can detect an absolute difference of 6% of advanced neoplasia with 80% power.

TC survivors treated with cisplatin-based chemotherapy can benefit from CRC surveillance. Evaluation of the diagnostic performance and patient acceptance of CRC surveillance is of importance to develop surveillance recommendations. Insight into the carcinogenesis of cisplatin-related advanced colorectal lesions will contribute to CRC prevention in the increasing number of TC survivors. The results may also be important for the many other cancer survivors treated with platinum-based chemotherapy.

Clinical Trials: NCT04180033, November 27, 2019, https://clinicaltrials.gov/ct2/show/NCT04180033 .

BMC gastroenterology. 2021 Feb 12*** epublish ***

Berbel L M Ykema, Tanya M Bisseling, Manon C W Spaander, Leon M G Moons, Dorien van der Biessen-van Beek, Lisette Saveur, Martijn Kerst, Sasja F Mulder, Ronald de Wit, Danielle Zweers, Gerrit A Meijer, Jos H Beijnen, Iris Lansdorp-Vogelaar, Flora E van Leeuwen, Petur Snaebjornsson, Monique E van Leerdam

Department of Gastroenterology and Hepatology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. ., Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands., Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands., Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands., Department of Gastroenterology and Hepatology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands., Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, The Netherlands., Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands., Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Pharmacy and Pharmacology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands., Department of Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.

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