Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180033
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 27, 2019
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE February 18, 2020
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
Diagnostic yield advanced colorectal neoplasia [ Time Frame: 2 years ]
Diagnostic yield of advanced colorectal neoplasia detection by a first colonoscopy surveillance.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • Features of colorectal neoplasia as classified during colonoscopy [ Time Frame: 2 years ]
    Colorectal neoplasia characteristics including endoscopic features (morphology, prevalence, size and location)
  • 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
  • Platinum levels in plasma [ Time Frame: 2 years ]
    Measure platinum in plasma and possibly in FFPE material of CRC
  • 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.
  • 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.
  • 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.
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • Features of colorectal neoplasia as classified during colonoscopy [ Time Frame: 2 years ]
    Colorectal neoplasia characteristics including endoscopic features (morphology, prevalence, size and location)
  • 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
  • Platinum levels in plasma [ Time Frame: 2 years ]
    Measure platinum in plasma and possibly in FFPE material of CRC
  • 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.
  • 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.
  • 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)
  • 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
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
Official Title  ICMJE Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Participants will be invited to undergo a colonoscopy surveillance.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Testicular Cancer
  • Colorectal Neoplasms
Intervention  ICMJE Diagnostic Test: Colonoscopy surveillance
Participants will be asked to undergo a first colonoscopy surveillance.
Other Name: Fecal immunochemical test (FIT)
Study Arms  ICMJE Colonoscopy surveillance in TC survivors
TC survivors treated with platinum-based chemotherapy will be invited to undergo a colonoscopy surveillance.
Intervention: Diagnostic Test: Colonoscopy surveillance
Publications * Ykema 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2019)
234
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Berbel Ykema, MD +31205129111 b.ykema@nki.nl
Contact: Martijn Kerst, MD PhD +31205129111 j.kerst@nki.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04180033
Other Study ID Numbers  ICMJE M19CTR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Monique van Leerdam, MD PhD Antoni van Leeuwenhoek Hospital
PRS Account The Netherlands Cancer Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP