Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy (CATCHER)

January 27, 2023 updated by: The Netherlands Cancer Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: Testicular cancer (TC) survivors have an increased risk of various second primary malignancies. A recent cohort study showed that platinum-based chemotherapy was associated with increased risk of colorectal cancer (CRC) in a dose dependent manner (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. However, the diagnostic yield, cost-effectiveness and burden of colonoscopy in TC survivors treated with platinum-based chemotherapy has never been assessed. Additionally, the molecular profile of advanced neoplastic lesions and CRC in TC survivors treated with platinum-based chemotherapy has not been established but can provide valuable insight into CRC carcinogenesis in this group of patients. Also the effectiveness of fecal tests has not been evaluated among TC survivors treated with platinum-based chemotherapy compared to that among population controls.

Objective: The primary objective of this study is to assess the diagnostic yield of colonoscopy surveillance in TC survivors treated with platinum-based chemotherapy. The secondary objectives are 1) to evaluate the molecular characteristics of colorectal (advanced) neoplasia in TC patients in relation to the cumulative doses of/ level of plasma cisplatin, in order to improve the understanding of CRC carcinogenesis following cisplatin exposure, 2) to determine the association of platinum levels in plasma with cumulative administered cisplatin doses as well as with presence of colorectal (advanced) neoplasia at colonoscopy and to determine the platinum amount in the colorectal tissue derived during primary colonoscopy screening, 3) to evaluate the cost-effectiveness and burden of colonoscopy. Our 4th secondary objective is to assess the effectiveness of a stool test for CRC screening in TC survivors compared to standard colonoscopy.

Study design: A multicentre prospective cross-sectional screening study.

Study population: TC survivors will be derived from an established, well-defined multicentre cohort. Inclusion criteria of this study are 1) participants should have been treated for TC in a participating Dutch hospital before the age of 50 years, 2) treatment consisted of at least three cycles of platinum-based chemotherapy (cisplatin) with or without additional radiotherapy, 3) participants should be at least 8 years after start of treatment, with a minimum age at first colonoscopy screening of 35 years, 4) the maximum age at participation is 75 years, 5) detection and potential treatment of advanced colorectal neoplasia is considered beneficial.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Antoni van Leeuwenhoek Hospital
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Medical Center
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3000 CA
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Colonoscopy surveillance in TC survivors
TC survivors treated with platinum-based chemotherapy will be invited to undergo a colonoscopy surveillance.
Diagnostic test: Colonoscopy surveillance
Participants will be asked to undergo a first colonoscopy surveillance.
Other Names:
  • Fecal immunochemical test (FIT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield advanced colorectal neoplasia
Time Frame: 2 years
Diagnostic yield of advanced colorectal neoplasia detection by a first colonoscopy surveillance.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Features of colorectal neoplasia as classified during colonoscopy
Time Frame: 2 years
Colorectal neoplasia characteristics including endoscopic features (morphology, prevalence, size and location)
2 years
Molecular features of colorectal neoplasia and normal mucosa as evaluated histopathologically, molecular and by immunohistochemistry
Time Frame: 6 months
The molecular profile of advanced colorectal neoplasia and normal colorectal tissue will be evaluated by immunohistochemistry and molecular pathology
6 months
Platinum levels in plasma
Time Frame: 2 years
Measure platinum in plasma and possibly in FFPE material of CRC
2 years
Fecal immunochemical test (FIT)
Time Frame: 2 years
Performance (sensitivity/specificity/positive predictive value/negative predictive value) of the fecal immunochemical test (FIT) stool test to detect advanced colorectal neoplasia will be evaluated using the colonoscopy as reference standard.
2 years
Determination of the most cost-effectiveness strategy for colonoscopy surveillance by using the MISCAN model
Time Frame: 3 months
Cost-effectiveness analysis of colonoscopy screening using the microsimulation screening analysis (MISCAN) model to evaluate the most cost-effective strategy.
3 months
Quality of life of participant before and after colonoscopy
Time Frame: 2 years

Quality of life before and after colonoscopy will be evaluated by validated questionnaires (EQ-5D). This is a standardized instrument to evaluate five health categories (mobility, self care, daily activities, pain/discomfort and fear/depression). The items can be scored in three values; no/some/a lot of problems. A higher score represents a worse outcome.

Furthermore, the health will be scored on a 0 to 100 scale. A higher score will correspond with a better health interpreted health of the participant.
2 years
Worries about cancer
Time Frame: 2 years
The cancer worry scale will be used to evaluate the worries about cancer (4 point scale; 1 (hardly never) to 4 (regularly() via a questionnaire before colonoscopy
2 years
Burden of colonoscopy
Time Frame: 2 years
Two questionnaire (before and after colonoscopy) will be performed to evaluate the expected and experienced burden of colonoscopy using a 5-point scale (1 - Hardly to 5 - Very)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Monique van Leerdam, MD PhD, Antoni van Leeuwenhoek Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 18, 2020

Primary Completion (ACTUAL)

November 25, 2022

Study Completion (ACTUAL)

November 25, 2022

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (ACTUAL)

November 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19CTR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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