Exploring blood biomarkers in colorectal cancer patients after liver surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut Bergonié
  Bordeaux, France Recruiting
• CHU Lille - Hôpital Huriez
  Lille, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting
• Hôpital Cochin
  Paris, France Recruiting
• Hôpital Pitié Salpêtrière
  Paris, France Recruiting
• Hôpital Saint Antoine
  Paris, France Recruiting

Study contacts

• Principal investigator: Maximiliano GELLI, MD — Department of Digestive Surgery, Gustave Roussy Hospital
• Study coordinator: Maximiliano GELLI, MD
• Email: maximiliano.gelli@gustaveroussy.fr
• Phone: +33(0)1 40 29 85 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.