Detecting treatment failure early in metastatic colorectal cancer patients
A Prospective Observational Cohort Study for Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients Undergoing Systemic Chemotherapy and Liver Resection With Curative Intent
This study is trying to find early signs in blood samples from patients with liver cancer to see if their treatment is working, so doctors can better tailor their care and avoid unnecessary procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05068531 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to gather real-world data from 100 patients with metastatic colorectal cancer limited to the liver, who are undergoing treatment with curative intent. The study will collect biospecimens over time to investigate early biological markers of treatment resistance and recurrence, focusing on circulating tumor DNA and other genetic and microbiome factors. By analyzing these markers, the research seeks to personalize therapy and potentially reduce unnecessary chemotherapy and surgeries for patients unlikely to benefit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage IV colon or rectal adenocarcinoma and liver-restricted metastases who are planned for curative surgery.
Not a fit: Patients with extra-hepatic metastases or those not scheduled for curative intent treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for metastatic colorectal cancer patients, improving outcomes and reducing unnecessary interventions.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing biological markers for treatment personalization in cancer care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients (≥18 years of age at the time of consent); 2. Stage IV colon or rectal adenocarcinoma with liver-restricted metastasis(es) for whom partial hepatectomy with curative intent is planned; 3. Instead of, or in addition to, partial hepatectomy, liver metastases may be ablated by needle radio frequency or microwave; in case of a solitary liver metastasis, three core-needle biopsies are provided for research at time of the procedure and prior to tissue destruction; 4. Patients may undergo planned two-stage partial hepatectomies; 5. Patients may have at baseline lung micro nodules or intra-abdominal enlarged nodes or nodules of unknown nature, not considered as extra-hepatic metastases in the opinion of the investigator; 6. Patients who are scheduled to receive FOLFOX-based pre-hepatectomy may receive any additional combined agents, such as and not limited to Irinotecan, anti-EGFR, and anti-VEGF drugs; 7. Patients are willing and able to provide serial blood samples, tumor and adjacent tissues, and stool samples for research; 8. The timing and specific treatments of the primary colon or rectal tumor is per SOC, at the discretion of the treating physician, including the use of pre-operative radiotherapy for rectal cancer; 9. Patients may receive post-operative adjuvant chemotherapy per SOC, at the discretion of the treating physician; 10. Patients must consent to the Exactis Personalized my Treatment registry. Exclusion Criteria: 1. Pregnant or breastfeeding patients, 2. Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome), and 3. Presence of concurrent other cancer(s).
Where this trial is running
Montreal, Quebec
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Simon Turcotte, MD, MSc — Chum
- Study coordinator: Wiam Belkaid, PhD
- Email: wiam.belkaid.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.