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

NCT ID: NCT03364621

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-29

Study Completion Date

2026-06-29

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Colorectal Cancer Metastatic Hepatic Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metastatic Colorectal Cancer with Isolated Liver Metastasis

Patients with advanced colorectal cancer with isolated liver metastasis. Primary cancer must be resectable (if no archival exists) and patient must be planned for liver resection with at least 3 cycles of chemotherapy prior to liver surgery.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Terry Fox Research Institute

OTHER

Sponsor Role collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lillian Siu, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Kyaw Aung, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Daniel Renouf, MD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Locations

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Vancouver Regional Cancer Centre

Vancouver, British Columbia, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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COMPARISON-001

Identifier Type: -

Identifier Source: org_study_id

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