Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04180033
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2019-11-06
Brief Title:
Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATCHER
Brief Summary:
Testicular cancer TC survivors treated with platinum-based chemotherapy have an increased risk of colorectal cancer CRC hazard ratio HR 39 for platinum-containing chemotherapy versus no platinum-containing chemotherapy 95 confidence interval 17-89 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
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 39 for platinum-containing chemotherapy versus no platinum-containing chemotherapy 95 confidence interval 17-89 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None