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

Colorectal Cancer Clinical Trial

— COMPARISON  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03364621
• Other study ID #: COMPARISON-001
• Status: Active, not recruiting
• Start date: August 29, 2017
• Est. completion date: June 29, 2025

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: June 29, 2025
• Est. primary completion date: June 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility Criteria:

1. Patients must have histologically confirmed CRC with isolated liver metastasis

2. Patients must be planned for a hepatic metastasectomy

3. Patients must have received at least 3 cycles of chemotherapy (FOLFOX or FOLFIRI with or without Bevacizumab) prior to the planned hepatic metastasectomy

4. Primary tumor must be considered resectable with a plan for this to either occur concurrently with the liver resection or subsequent to this.

5. If primary has already been resected before liver resection, archival tissue must be available for genomic analysis

6. Patients must be 18yrs of age or older

7. Ability to understand and willing to sign a written informed consent document

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Hepatic Metastases
• Neoplasm Metastasis

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Vancouver Regional Cancer Centre	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	British Columbia Cancer Agency, Terry Fox Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments		5 years
Secondary	Identification of epigenetic profiles of recurring tumor clones through serial DNA characterization on the NGS platform		5 years
Secondary	Identification of epigenetic profiles of recurring tumor clones through serial RNA characterization on the NGS platform		5 years
Secondary	Identification of DNA methylation profiles of recurring tumor clones through serial methylome analysis via MethylSeq		5 years
Secondary	Non-invasive detection of cfDNA methylation profiles by performing ultra-deep targeted NGS on blood samples		5 years
Secondary	Non-invasive detection of cfDNA methylation profiles by performing cfMeDIP-seq on blood samples		5 years