Diagnostic yield of screening colonoscopy in testicular cancer survivors treated with platinum-based chemotherapy

Diagnostic yield of screening colonoscopy in testicular cancer survivors treated with platinum-based chemotherapy - CATCHER

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48363

Enrollment

234

Registered

2019-09-11

Start date

2021-02-18

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(sessile) polyps adenomas neoplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 75 years - Detection and potential treatment of advanced colorectal neoplasia is considered useful

Exclusion criteria

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 (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 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

Design outcomes

Primary

Measure	Time frame
To determine the diagnostic yield of advanced colorectal neoplasia by screening colonoscopy in TC survivors treated with platinum-based chemotherapy	—

Secondary

Measure	Time frame
- To determine whether the molecular profile of colorectal neoplasia in TC survivors treated with platinum-based chemotherapy differs from sporadic colorectal neoplasia - To examine whether we can detect platinum in plasma and if so to examine whether platinum levels are associated with the outcome of advanced colorectal lesions and cumulative cisplatin dose - To develop colonoscopy surveillance screening recommendations for TC survivors treated with platinum-based chemotherapy - To evaluate the burden of screening colonoscopy in TC survivors treated with platinum-based chemotherapy - To evaluate the cost-effectiveness of colonoscopy in TC survivors treated with platinum-based chemotherapy - To evaluate the sensitivity and specificity of stool tests for detecting advanced colorectal neoplasia in TC survivors treated with platinum-based chemotherapy	—

Measure

Time frame

- To determine whether the molecular profile of colorectal neoplasia in TC survivors treated with platinum-based chemotherapy differs from sporadic colorectal neoplasia - To examine whether we can detect platinum in plasma and if so to examine whether platinum levels are associated with the outcome of advanced colorectal lesions and cumulative cisplatin dose - To develop colonoscopy surveillance screening recommendations for TC survivors treated with platinum-based chemotherapy - To evaluate the burden of screening colonoscopy in TC survivors treated with platinum-based chemotherapy - To evaluate the cost-effectiveness of colonoscopy in TC survivors treated with platinum-based chemotherapy - To evaluate the sensitivity and specificity of stool tests for detecting advanced colorectal neoplasia in TC survivors treated with platinum-based chemotherapy

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Countries

Netherlands

Outcome results