Skip to main content
Clinical Trials/NCT05787197
NCT05787197
Recruiting
Not Applicable

Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort

GERCOR - Multidisciplinary Oncology Cooperative Group16 sites in 1 country232 target enrollmentJanuary 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Colorectal Cancer
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Enrollment
232
Locations
16
Primary Endpoint
Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.

Detailed Description

Blood collection times according to specific clinical situations: * Standard approach * Combined surgery * Reverse strategy * Two-stage hepatectomy

Registry
clinicaltrials.gov
Start Date
January 9, 2024
End Date
June 30, 2027
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)

Time Frame: Up to 36 months

DFS is defined as the time from complete surgical resection (following first surgery if one-stage surgery or second surgery if two-stage strategy) to first documented event (relapse or death, whichever occurred first), or until last contact if no event occurs.

Secondary Outcomes

  • Prognostic factor(s) for disease recurrence and survival.(Up to 4 years)
  • Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.(Up to 4 years)
  • Overall survival (OS) n patients who undergo curative-intent resection of CRLM.(Up to 4 years)
  • Prognostic value of ctDNA(Up to 4 years)
  • Association between ctDNA and clinical features.(Up to 4 years)
  • Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.(Up to 4 years)

Study Sites (16)

Loading locations...

Similar Trials