NCT03364621

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Aug 2017Jun 2026

Study Start

First participant enrolled

August 29, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2026

Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

8.8 years

First QC Date

November 9, 2017

Last Update Submit

June 27, 2025

Conditions

Colorectal CancerColorectal Cancer MetastaticHepatic Metastases

Keywords

Liver resectionMetastasisMolecular profilingEpigenetic analysisGenomic analysisSequencing

Outcome Measures

Primary Outcomes (1)

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

    5 years

Secondary Outcomes (5)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vancouver Regional Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

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

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

December 6, 2017

Study Start

August 29, 2017

Primary Completion (Estimated)

June 29, 2026

Study Completion (Estimated)

June 29, 2026

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations

CA(2)