Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- University Health Network, Toronto
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments
- Status
- Active, Not Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
- •Patients with evidence of possible metastatic disease at any sites outside the liver are not eligible
- •Patients with any major co-morbidity or co-morbidities that will render liver resection very high risk in investigator's opinion
- •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.
- •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.
Outcomes
Primary Outcomes
Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments
Time Frame: 5 years
Secondary Outcomes
- 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)