Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study
| العنوان: | Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study |
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| المؤلفون: | Gerrit A. Meijer, Monique E. van Leerdam, Ronald de Wit, Petur Snaebjornsson, Berbel L. M. Ykema, Leon M G Moons, Iris Lansdorp-Vogelaar, Martijn Kerst, Sasja F. Mulder, Danielle Zweers, Tanya M. Bisseling, Jos H. Beijnen, Dorien van der Biessen-van Beek, Manon C.W. Spaander, Flora E. van Leeuwen, Lisette Saveur |
| المساهمون: | Gastroenterology & Hepatology, Medical Oncology, Public Health |
| المصدر: | BMC Gastroenterology, 21(1). BMC BMC Gastroenterology BMC Gastroenterology, 21(1):67. BioMed Central Ltd. BMC Gastroenterology, 21 BMC Gastroenterology, 21, 1 BMC Gastroenterology, Vol 21, Iss 1, Pp 1-7 (2021) |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, Male, medicine.medical_specialty, Colorectal cancer, Carcinogenesis, Colonoscopy, Cohort Studies, 03 medical and health sciences, Study Protocol, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Cancer Survivors, Testicular Neoplasms, Testicular cancer, Internal medicine, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14], medicine, Humans, Multicenter Studies as Topic, Colorectal neoplasia, Prospective Studies, Survivors, lcsh:RC799-869, Early Detection of Cancer, Platinum, Platinum-based chemotherapy, Surveillance, medicine.diagnostic_test, business.industry, Incidence (epidemiology), Other Research Radboud Institute for Health Sciences [Radboudumc 0], Hazard ratio, Gastroenterology, Cancer, General Medicine, Middle Aged, medicine.disease, Clinical trial, Cross-Sectional Studies, 030220 oncology & carcinogenesis, lcsh:Diseases of the digestive system. Gastroenterology, 030211 gastroenterology & hepatology, business, Colorectal Neoplasms, Cohort study |
| الوصف: | BackgroundTesticular 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.MethodsThis 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.DiscussionTC 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.Trial registrationClinical Trials: NCT04180033, November 27, 2019,https://clinicaltrials.gov/ct2/show/NCT04180033Test. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1471-230X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4f4ff9ea80b6b8d984624169873343a8Test https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-021-01639-2Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4f4ff9ea80b6b8d984624169873343a8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1471230X |
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