Clinical trial · Interventional
Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Testicular cancer (TC) survivors treated with platinum-based chemotherapy have an increased risk of colorectal cancer (CRC) (hazard ratio (HR) 3.9 for platinum-containing chemotherapy versus no platinum-containing chemotherapy, 95% confidence interval 1.7-8.9). Colonoscopy screening can reduce CRC incidence and mortality. Given this increased risk of CRC, colonoscopy surveillance should be considered for TC survivors treated with platinum-based chemotherapy. The aim of this study is to evaluate the diagnostic yield of advanced colorectal neoplasia during colonoscopy surveillance in TC survivors treated with platinum-based chemotherapy. The secondary objectives are to determine cost-effectiveness and burden of colonoscopy. Furthermore, the molecular profile of advanced neoplasia will be evaluated to create insight into the carcinogenesis. The effectiveness of fecal immunochemical testing (FIT) will be evaluated with colonoscopy as a reference. Finally, blood plasma platinum-levels will be determined to examine a potential correlation with the outcome of the ccolonoscopy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy surveillance | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Colonoscopy surveillance in TC survivors
- description
- TC survivors treated with platinum-based chemotherapy will be invited to undergo a colonoscopy surveillance.
- interventionNames
- Diagnostic Test: Colonoscopy surveillance
Primary outcomes (1)
- measure
- Diagnostic yield advanced colorectal neoplasia
- timeFrame
- 2 years
- description
- Diagnostic yield of advanced colorectal neoplasia detection by a first colonoscopy surveillance.
Secondary outcomes (8)
- measure
- Features of colorectal neoplasia as classified during colonoscopy
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of TC before age of 50 years * Treatment of primary TC consisting at least: three cycles of platinum-based chemotherapy consisting of cisplatin * At least 8 years after initial treatment * At least 35 years of age and not older than 70 75 years * Detection and potential treatment of advanced colorectal neoplasia is considered beneficial Exclusion Criteria: * A history of a proctocolectomy * Colonoscopy surveillance for other indications (including hereditary CRC syndrome, familial CRC syndrome, inflammatory bowel disease, history of colorectal adenoma or CRC). Result of the prior colonoscopy will be put in the database and used for additional analyses * Having received a colonoscopy in the past three years * Currently receiving cytotoxic treatment or radiotherapy for malignant disease * Coagulopathy (prothrombin time \<50% of control; partial tromboplastin time \>50 seconds) or anticoagulants (fenprocoumon, acenocoumarol, platelet aggregation inhibitors or new oral anticoagulants) that cannot be stopped or safely bridged if necessary * Comorbidity leading to an impaired physical performance (World health organization (WHO) performance status 3-4) or mental retardation * Limited Dutch language skills * No informed consent
References
Publications (2)
- DERIVEDBreekveldt ECH, Ykema BLM, Huitema ADR, Gietema JA, Beijnen JH, Snaebjornsson P, Schaapveld M, van Leeuwen FE, Rosing H, van Leerdam ME; CATCHER study working group. Platinum retention in plasma, urine, and normal colonic mucosa in cisplatin-treated testicular cancer survivors. PLoS One. 2024 Nov 14;19(11):e0312994. doi: 10.1371/journal.pone.0312994. eCollection 2024. PMID 39541403
- DERIVEDYkema BLM, Bisseling TM, Spaander MCW, Moons LMG, van der Biessen-van Beek D, Saveur L, Kerst M, Mulder SF, de Wit R, Zweers D, Meijer GA, Beijnen JH, Lansdorp-Vogelaar I, van Leeuwen FE, Snaebjornsson P, van Leerdam ME. Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study. BMC Gastroenterol. 2021 Feb 12;21(1):67. doi: 10.1186/s12876-021-01639-2. PMID 33579196