Status:
ACTIVE_NOT_RECRUITING
Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Terry Fox Research Institute
British Columbia Cancer Agency
Conditions:
Colorectal Cancer
Colorectal Cancer Metastatic
Eligibility:
All Genders
18+ years
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...
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 Patie...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 29 2026
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03364621
Start Date
August 29 2017
End Date
June 29 2026
Last Update
July 2 2025
Active Locations (2)
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1
Vancouver Regional Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9