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

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ClinicalTrials.gov Identifier: NCT03364621
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : November 8, 2019
Sponsor:
Collaborators:
Terry Fox Research Institute
British Columbia Cancer Agency
Information provided by (Responsible Party):
University Health Network, Toronto

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
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.

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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 : August 29, 2017
Estimated Primary Completion Date : August 29, 2022
Estimated Study Completion Date : August 29, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Identification of epigenetic profiles of recurring tumor clones through serial DNA characterization on the NGS platform [ Time Frame: 5 years ]
  2. Identification of epigenetic profiles of recurring tumor clones through serial RNA characterization on the NGS platform [ Time Frame: 5 years ]
  3. Identification of DNA methylation profiles of recurring tumor clones through serial methylome analysis via MethylSeq [ Time Frame: 5 years ]
  4. Non-invasive detection of cfDNA methylation profiles by performing ultra-deep targeted NGS on blood samples [ Time Frame: 5 years ]
  5. Non-invasive detection of cfDNA methylation profiles by performing cfMeDIP-seq on blood samples [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Archival primary tumor tissue, fresh liver tumor tissue, baseline tube whole blood, serial 4x tube of whole blood every 3-6 months until disease relapse or 2 years post-liver resection


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
metastatic colorectal cancer, isolated liver metastases, at least 3 rounds of chemotherapy (FOLFOX or FOLFIRI +/- Bevacizumab) prior to planned liver resection
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364621


Locations
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Canada, British Columbia
Vancouver Regional Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Terry Fox Research Institute
British Columbia Cancer Agency
Investigators
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Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre
Principal Investigator: Kyaw Aung, MD Princess Margaret Cancer Centre
Principal Investigator: Daniel Renouf, MD British Columbia Cancer Agency

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03364621     History of Changes
Other Study ID Numbers: COMPARISON-001
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Liver resection
Metastasis
Molecular profiling
Epigenetic analysis
Genomic analysis
Sequencing
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Extracts
Hematinics