Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
Condition: Testicular Cancer; Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms; Testicular Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Colonoscopy surveillance
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will be asked to undergo a first colonoscopy surveillance.
Other intervention name(s): Fecal immunochemical test (FIT)
Intervention model: Single Group Assignment
Intervention model description: Participants will be invited to undergo a colonoscopy surveillance.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Colonoscopy surveillance