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

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



Sponsors


Source

University Health Network, Toronto

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-08-29

Completion Date

2022-08-29

Primary Completion Date

2022-08-29

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

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

Secondary Outcome

Measure

Time Frame

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

Number Of Groups

1

Enrollment

20

Conditions


Eligibility

Study Pop

metastatic colorectal cancer, isolated liver metastases, at least 3 rounds of chemotherapy
(FOLFOX or FOLFIRI +/- Bevacizumab) prior to planned liver resection

Sampling Method

Probability Sample

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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Lillian Siu, MD
Principal Investigator
Princess Margaret Cancer Centre
Kyaw Aung, MD
Principal Investigator
Princess Margaret Cancer Centre
Daniel Renouf, MD
Principal Investigator
British Columbia Cancer Agency

Overall Contact

Last Name

Helen Chow

Phone

416-946-4501

Phone Ext

5281

Email



Location

Facility

Status

Contact

Investigator

Vancouver Regional Cancer Centre
Vancouver British Columbia V5Z 4E6 Canada
Not yet recruiting
Last Name: Christina Vine
Phone: 604-877-6000
Phone Ext: L672806
Email: [email protected]
Last Name: Daniel Renouf, MD
Role: Principal Investigator
Princess Margaret Cancer Centre
Toronto Ontario M5G 2M9 Canada
Recruiting
Last Name: Catherine Ho
Phone: 416-946-4501
Phone Ext: 3486
Email: [email protected]
Last Name: Lillian Siu, MD
Role: Principal Investigator

Last Name: Kyaw Aung, MD
Role: Principal Investigator


Location Countries

Country

Canada


Verification Date

2017-11-01

Lastchanged Date

2017-11-30

Firstreceived Date

2017-11-09

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Metastatic Colorectal Cancer with Isolated Liver Metastasis

Description

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.


Firstreceived Results Date

N/A

Biospec Retention

Samples With DNA

Biospec Descr

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

Acronym

COMPARISON

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

November 9, 2017

Study First Submitted Qc

November 30, 2017

Study First Posted

December 6, 2017

Last Update Submitted

November 30, 2017

Last Update Submitted Qc

November 30, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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