Colorectal CancerCOMPARISONNCT03364621
Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy
An observational study of Colorectal Cancer and Colorectal Cancer Metastatic, run by University Health Network, Toronto at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Cancer Metastatic, Hepatic Metastases
- How many people
- 17 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Aug 2017to 29 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: metastatic colorectal cancer, isolated liver metastases, at least 3 rounds of chemotherapy (FOLFOX or FOLFIRI +/- Bevacizumab) prior to planned liver resection
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Vancouver Regional Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
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.
Read the 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.
- Keywords
- Liver resection, Metastasis, Molecular profiling, Epigenetic analysis, Genomic analysis, Sequencing
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments
Measured: 5 years
Secondary outcomes (5)
Identification of epigenetic profiles of recurring tumor clones through serial DNA characterization on the NGS platform
Measured: 5 years
Identification of epigenetic profiles of recurring tumor clones through serial RNA characterization on the NGS platform
Measured: 5 years
Identification of DNA methylation profiles of recurring tumor clones through serial methylome analysis via MethylSeq
Measured: 5 years
Non-invasive detection of cfDNA methylation profiles by performing ultra-deep targeted NGS on blood samples
Measured: 5 years
Non-invasive detection of cfDNA methylation profiles by performing cfMeDIP-seq on blood samples
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start29 Aug 2017
- Primary completion29 Jun 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Terry Fox Research Institute, British Columbia Cancer Agency
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, Princess Margaret Cancer CentreKyaw Aung, MD, Principal investigator, Princess Margaret Cancer CentreDaniel Renouf, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364621
- Sponsor's protocol ID
- COMPARISON-001
- Acronym
- COMPARISON
- Status last verified
- Sep 2026
- First submitted
- 9 Nov 2017
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy
- ClinicalTrials.gov ID
- NCT03364621
- Acronym / sponsor ID
- COMPARISON / COMPARISON-001
- Keywords
- Liver resection, Metastasis, Molecular profiling, Epigenetic analysis, Genomic analysis, Sequencing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Terry Fox Research Institute, British Columbia Cancer Agency
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic colorectal cancer, isolated liver metastases, at least 3 rounds of chemotherapy (FOLFOX or FOLFIRI +/- Bevacizumab) prior to planned liver resection
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments
Time frame: 5 years
5 secondary outcomes
Identification of epigenetic profiles of recurring tumor clones through serial DNA characterization on the NGS platform
Time frame: 5 years
Identification of epigenetic profiles of recurring tumor clones through serial RNA characterization on the NGS platform
Time frame: 5 years
Identification of DNA methylation profiles of recurring tumor clones through serial methylome analysis via MethylSeq
Time frame: 5 years
Non-invasive detection of cfDNA methylation profiles by performing ultra-deep targeted NGS on blood samples
Time frame: 5 years
Non-invasive detection of cfDNA methylation profiles by performing cfMeDIP-seq on blood samples
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Cancer Metastatic, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization rates of characterized genomic and epigenetic features associated with chemotherapy resistance and tumor recurrence in clinical environments (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.