ClinicalTrials.gg
Active, not recruitingNCT03364621COMPARISONUpdated Sep 28, 2026

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

An observational study in Colorectal Cancer, Colorectal Cancer Metastatic and Hepatic Metastases, sponsored by University Health Network, Toronto. Active, not recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by University Health Network, Toronto · Observational

Updated Sep 28, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 25 studies in Colorectal Neoplasms by University Health Network, Toronto — 7 open to participants now, 12 under way, none of them phase 3. Colorectal Neoplasms · University Health Network, Toronto.

Enrollment
10th of 10
17 · median 220
Started
2017
the only one that year
Observational
10 of 25
4 open now
Primary completion
2027-06
later than 6 of 11 live
Registered
18th of 25
by date

Among the 25 studies in Colorectal Neoplasms by University Health Network, Toronto, this one is the 10th largest by enrollment of the 10 observational ones that give a count, is the only one that started in 2017, is one of 10 observational ones, reaches primary completion later than 6 of the 11 other live ones, and was the 18th registered.

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

7 of the 25 studies in Colorectal Neoplasms by University Health Network, Toronto are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Colorectal Neoplasms by University Health Network, Toronto, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Colorectal Cancer
  • Colorectal Cancer Metastatic
  • Hepatic Metastases

Keywords

  • Liver resection
  • Metastasis
  • Molecular profiling
  • Epigenetic analysis
  • Genomic analysis
  • Sequencing
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Eligibility criteria

Eligibility Criteria:

  1. Patients must have confirmed CRC with isolated liver
  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, 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 5 years

Secondary outcomes

  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

07

Study locations

2 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2017 (actual). Primary completion is estimated for Jun 2027, 118 months after the start.

Of 529 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 118 months is above that.

Counting every sponsor, half of 646 studies reached it within 52 months; a quarter within 27 and three quarters within 104.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion Jun 2026 → Jun 2027 and completion Jun 2026 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2017
First posted
Dec 6, 2017
StartActual
Aug 29, 2017
Primary completionEst.
Jun 29, 2027was Jun 2026
CompletionEst.
Jun 29, 2027was Jun 2026
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jun 29, 2026→Jun 29, 2027
Sep 28, 2026
Study completion
Jun 29, 2026→Jun 29, 2027
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Primary completion Jun 29, 2026→Jun 29, 2027
    Study completion Jun 29, 2026→Jun 29, 2027
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT03364621
Collaborators
Terry Fox Research Institute, British Columbia Cancer Agency
Responsible party
Sponsor
First posted
Dec 6, 2017
Start date
Aug 29, 2017
Primary completion
Jun 29, 2027 (estimated)
Completion
Jun 29, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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