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

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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

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.


Condition or disease Intervention/treatment Phase
Testicular Cancer Colorectal Neoplasms Diagnostic Test: Colonoscopy surveillance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
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
Official Title: Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Fecal immunochemical test (FIT)




Primary Outcome Measures :
  1. Diagnostic yield advanced colorectal neoplasia [ Time Frame: 2 years ]
    Diagnostic yield of advanced colorectal neoplasia detection by a first colonoscopy surveillance.


Secondary Outcome Measures :
  1. Features of colorectal neoplasia as classified during colonoscopy [ Time Frame: 2 years ]
    Colorectal neoplasia characteristics including endoscopic features (morphology, prevalence, size and location)

  2. 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

  3. Platinum levels in plasma [ Time Frame: 2 years ]
    Measure platinum in plasma and possibly in FFPE material of CRC

  4. 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.

  5. 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.

  6. 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.


  7. 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

  8. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180033


Contacts
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Contact: Berbel Ykema, MD +31205129111 b.ykema@nki.nl
Contact: Martijn Kerst, MD PhD +31205129111 j.kerst@nki.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Tanya Bisseling, MD PhD    +3124361111    tanya.bisseling@radboudumc.nl   
Contact: Sasja Mulder, MD PhD    +3124361111    sasja.mulder@radboudumc.nl   
Erasmus Medical Center Not yet recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000 CA
Contact: Manon Spaander, MD PhD    +31107040704    v.spaander@erasmusmc.nl   
Contact: Ronald de Wit, Prof    +31107040704    r.dewit@erasmusmc.nl   
Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Monique van Leerdam, MD PhD    +31205129111    m.v.leerdam@nki.nl   
Contact: Berbel Ykema, MD    +31205129111    b.ykema@nki.nl   
Sub-Investigator: Martijn Kerst, MD PhD         
University Medical Center Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Leon Moons, MD PhD    +31887555555    l.m.g.moons@umcutrecht.nl   
Contact: Gerard Groenewegen, MD PhD    +31887555555    g.groenewegen@umcutrecht.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Monique van Leerdam, MD PhD Antoni van Leeuwenhoek Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT04180033    
Other Study ID Numbers: M19CTR
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
Colonoscopy surveillance
Additional relevant MeSH terms:
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Colorectal Neoplasms
Testicular Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders