Exploring blood biomarkers in colorectal cancer patients after liver surgery

Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort

This study is testing if blood samples can help predict how well colorectal cancer patients do after surgery to remove liver tumors.

Quick facts

• Study type: Observational
• Enrollment: 232 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 16 sites (Besançon and 15 other locations)
• Trial ID: NCT05787197 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the prognostic value of circulating tumor DNA (ctDNA) in patients with metastatic colorectal cancer who are undergoing curative-intent surgical resection for liver metastases. It involves a multicenter cohort design where blood samples will be collected at various clinical stages to assess disease response and the likelihood of recurrence or death. The study will include patients who have histologically confirmed colorectal adenocarcinoma and are eligible for surgery, with a focus on those with isolated resectable liver metastases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed colorectal adenocarcinoma and isolated resectable liver metastases.

Not a fit: Patients with non-resectable liver metastases or those with significant extrahepatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a reliable biomarker for predicting disease outcomes in colorectal cancer patients after liver surgery.

How similar studies have performed: Previous studies have shown promise in using ctDNA as a biomarker in various cancers, indicating potential success for this approach in colorectal cancer.

Eligibility criteria

Inclusion criteria

The patient will be included if:

1. Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,
2. Is ≥ 18 years of age,
3. Has histologically confirmed colorectal adenocarcinoma,
4. Has resected primary tumor or is eligible to primary tumor and CRLM (in case of synchronous metastases) resection within 6 months prior to study inclusion,
5. Has isolated CRLM that is deemed resectable or potentially resectable (extrahepatic metastases excluded, except infracentimetric non-specific lung lesions with largest diameter \<1 cm and maximal number of ≤3) as judged by a multidisciplinary team meeting (based on CT scans of chest, abdomen, and pelvis \[or MRI if CT not possible\]),
6. Is eligible to surgical procedure,
7. Is fit for the chemotherapy-surgery combination treatment,
8. Is registered in a national health care system (Protection Universelle Maladie \[PUMa\] included).

Exclusion criteria

The patient will be excluded if:

1. Has definitively unresectable CLRM,
2. Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,
3. Has not resected primary rectal tumor (low and middle),
4. Has history of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix,
5. Has no more than two surgical procedures planned for complete resection of primary tumor and/or liver metastases,
6. Has deficient mismatch repair (dMMR)/ microsatellite instability (MSI) tumors treated with immunotherapy,
7. Blood samples cannot be collected if surgical procedure,
8. Is pregnant or breastfeeding,
9. Cannot be followed-up due to geographical, social, or psychic conditions,
10. Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,
11. Is under guardianship, curatorship, or under the protection of justice.

Where this trial is running

Besançon and 15 other locations

• CHU Jean Minjoz — Besançon, France (Not_yet_recruiting)
• Institut Bergonié — Bordeaux, France (Recruiting)
• CHU Lille - Hôpital Huriez — Lille, France (Recruiting)
• Centre Léon Bérard — Lyon, France (Recruiting)
• Hôpital Bichât Claude Bernard — Paris, France (Not_yet_recruiting)
• Hôpital Cochin — Paris, France (Recruiting)
• Hôpital Pitié Salpêtrière — Paris, France (Recruiting)
• Hôpital Saint Antoine — Paris, France (Recruiting)
• Institut Mutualiste Montsouris — Paris, France (Recruiting)
• Hôpital Haut Lévêque — Pessac, France (Recruiting)
• CHU de Poitiers — Poitiers, France (Recruiting)
• CHU Rouen — Rouen, France (Not_yet_recruiting)
• CHU Strasbourg — Strasbourg, France (Recruiting)
• CHRU Tours — Tours, France (Recruiting)
• Hôpital Paul Brousse — Villejuif, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Recruiting)

Study contacts

• Principal investigator: Maximiliano GELLI, MD — Department of Digestive Surgery, Gustave Roussy Hospital
• Study coordinator: Maximiliano GELLI, MD

Conditions Metastatic Colorectal Cancer; Circulating Tumor DNA