ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases (CLIMES)

July 22, 2025 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Blood collection times according to specific clinical situations:

  • Standard approach
  • Combined surgery
  • Reverse strategy
  • Two-stage hepatectomy

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Besançon, France
        • Not yet recruiting
        • Chu Jean Minjoz
        • Contact:
          • Christophe BORG, MD
      • Bordeaux, France
        • Recruiting
        • Institut Bergonie
        • Contact:
          • Grégoire DESOLNEUX, MD
      • Lille, France
        • Recruiting
        • CHU Lille - Hôpital Huriez
        • Contact:
          • Stéphanie TRUANT, MD
      • Lyon, France
        • Recruiting
        • Centre Léon Bérard
        • Contact:
          • Aurélien DUPRE, MD
      • Paris, France
        • Recruiting
        • Hôpital Cochin
        • Contact:
          • David FUKS, MD
      • Paris, France
        • Recruiting
        • Hopital Saint Antoine
        • Contact:
          • François PAYE, MD
      • Paris, France
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
          • David MLAKA, MD
      • Paris, France
        • Recruiting
        • Hôpital Pitie Salpétrière
        • Contact:
          • Claire GOUMARD, MD
      • Paris, France
        • Not yet recruiting
        • Hopital Bichat Claude Bernard
        • Contact:
          • Gaël GOUJON, MD
      • Pessac, France
        • Recruiting
        • Hopital Haut Lévêque
        • Contact:
          • Denis SMITH, MD
      • Poitiers, France
        • Recruiting
        • CHU De Poitiers
        • Contact:
          • Camille EVRARD, MD
      • Rouen, France
        • Not yet recruiting
        • CHU Rouen
        • Contact:
          • Frédéric FIORE, MD
      • Strasbourg, France
        • Recruiting
        • CHU Strasbourg
        • Contact:
          • Pietro ADDEO, MD
      • Tours, France
        • Recruiting
        • Chru Tours
        • Contact:
          • Petru BUCUR, MD
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Maximiliano GELLI, MD
      • Villejuif, France
        • Recruiting
        • Hôpital Paul Brousse
        • Contact:
          • René ADAM, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Active file in oncology department

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)
Time Frame: Up to 36 months
DFS is defined as the time from complete surgical resection (following first surgery if one-stage surgery or second surgery if two-stage strategy) to first documented event (relapse or death, whichever occurred first), or until last contact if no event occurs.
Up to 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.
Time Frame: Up to 4 years
EFS is defined as time between inclusion until the occurrence of an event: disease progression, relapse, disease progression, or death from any reason.
Up to 4 years
Overall survival (OS) n patients who undergo curative-intent resection of CRLM.
Time Frame: Up to 4 years
OS is defined as the time between inclusion and death. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
Up to 4 years
Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.
Time Frame: Up to 4 years
TFS is defined as the time from initial surgery until the first unresectable recurrence or death from any cause or the date of the last follow-up, at which point data are censored.
Up to 4 years
Prognostic value of ctDNA
Time Frame: Up to 4 years

Prognostic value of ctDNA:

  • post-operative ctDNA detection,
  • relative change in ctDNA level after curative resection of CRLM,
  • ctDNA in different subgroups of patients classified according to the type of surgical strategy (standard approach, combined surgery, reverse strategy, two-staged hepatectomy),
Up to 4 years
Prognostic factor(s) for disease recurrence and survival.
Time Frame: Up to 4 years
Prognostic factor(s) for disease recurrence and survival in patients who undergo curative-intent resection of CRLM.
Up to 4 years
Association between ctDNA and clinical features.
Time Frame: Up to 4 years
To identify the clinical, biological, and pathological factors associated with the ctDNA level.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maximiliano GELLI, MD, Department of Digestive Surgery, Gustave Roussy Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIMES G-118 CIRCULATE-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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