Diagnostic yield of screening colonoscopy in testicular cancer survivors treated with platinum-based chemotherapy
- Conditions
- (sessile) polypsadenomasneoplasia1001799010017987
- Registration Number
- NL-OMON48363
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 234
- 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 75 years
- Detection and potential treatment of advanced colorectal neoplasia is
considered useful
- 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 (however the result of
the prior colonoscopy will be put in the database and used for additional
analyses )
- 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
savely bridged
- 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the diagnostic yield of advanced colorectal neoplasia by screening<br /><br>colonoscopy in TC survivors treated with platinum-based chemotherapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To determine whether the molecular profile of colorectal neoplasia in TC<br /><br>survivors treated with platinum-based chemotherapy differs from sporadic<br /><br>colorectal neoplasia<br /><br>- To examine whether we can detect platinum in plasma and if so to examine<br /><br>whether platinum levels are associated with the outcome of advanced colorectal<br /><br>lesions and cumulative cisplatin dose<br /><br>- To develop colonoscopy surveillance screening recommendations for TC<br /><br>survivors treated with platinum-based chemotherapy<br /><br>- To evaluate the burden of screening colonoscopy in TC survivors treated with<br /><br>platinum-based chemotherapy<br /><br>- To evaluate the cost-effectiveness of colonoscopy in TC survivors treated<br /><br>with platinum-based chemotherapy<br /><br>- To evaluate the sensitivity and specificity of stool tests for detecting<br /><br>advanced colorectal neoplasia in TC survivors treated with platinum-based<br /><br>chemotherapy</p><br>