Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy

Active, not recruiting

• Conditions: Colorectal Cancer; Hepatic Metastases; Colorectal Cancer Metastatic

• Registration Number: NCT03364621
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This is a prospective study investigating the disease course of patients with colorectal cancer that have had their cancer spread to their liver. The aim of this study is find potential biomarkers for disease recurrence and therapeutic targets for prognostic information.

Detailed Description

Colorectal cancer (CRC), the 2nd leading cause of cancer mortality, often has a pattern of targeting the liver during initial metastases. The Comprehensive Genomic Profiling of Colorectal Cancer Patients with Isolated Liver Metastases to Understand Response and Resistance to Cancer Therapy (COMPARISON) study aims to assess the disease course of CRC by collecting primary tumor and metastatic liver specimens following pre-operative chemotherapy. If relapse occurs following surgical resection of the liver, biopsies will also be done for molecular analysis. As a result, these samples can be analyzed for chemotherapy resistance mechanisms and therapeutic targets to determine potential clinical outcomes for this particular subset of CRC patients.

Study Timeline

• Study Start: 2017-08-29
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-06-29
• Study Completion: 2025-06-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with un-resectable or borderline resectable isolated liver metastases as judged by the multidisciplinary hepatobiliary tumor board at PM or BCCA after a course of pre-operative chemotherapy will be excluded
2. Patients with evidence of possible metastatic disease at any sites outside the liver are not eligible
3. Patients with any major co-morbidity or co-morbidities that will render liver resection very high risk in investigator's opinion
4. Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
5. Patients with a previous history of another primary cancer treated within 5 years of study entry are not eligible except those with basal cell or squamous cell carcinoma of the skin and intraepithelial neoplasia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments	5 years

Secondary Outcome Measures

Name	Time	Method
Identification of epigenetic profiles of recurring tumor clones through serial RNA characterization on the NGS platform	5 years
Identification of DNA methylation profiles of recurring tumor clones through serial methylome analysis via MethylSeq	5 years
Non-invasive detection of cfDNA methylation profiles by performing ultra-deep targeted NGS on blood samples	5 years
Non-invasive detection of cfDNA methylation profiles by performing cfMeDIP-seq on blood samples	5 years
Identification of epigenetic profiles of recurring tumor clones through serial DNA characterization on the NGS platform	5 years

Trial Locations

Locations (2)

Vancouver Regional Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada