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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03364621

Collaborator

Terry Fox Research Institute (Other), British Columbia Cancer Agency (Other)

Enrollment

Locations

Anticipated Duration (Months)

8.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colorectal Cancer Metastatic Hepatic Metastases

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 Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 29, 2017

Anticipated Primary Completion Date :

Aug 29, 2023

Anticipated Study Completion Date :

Aug 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments [5 years]

Secondary Outcome Measures

Identification of epigenetic profiles of recurring tumor clones through serial DNA characterization on the NGS platform [5 years]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Eligibility Criteria:

Patients must have histologically confirmed CRC with isolated liver metastasis
Patients must be planned for a hepatic metastasectomy
Patients must have received at least 3 cycles of chemotherapy (FOLFOX or FOLFIRI with or without Bevacizumab) prior to the planned hepatic metastasectomy
Primary tumor must be considered resectable with a plan for this to either occur concurrently with the liver resection or subsequent to this.
If primary has already been resected before liver resection, archival tissue must be available for genomic analysis
Patients must be 18yrs of age or older
Ability to understand and willing to sign a written informed consent document

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.