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Metastatic Colorectal CancerCLIMESNCT05787197

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

An observational study of Metastatic Colorectal Cancer and Circulating Tumor DNA, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 16 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
232 participants
Where
16 sitesFrance
Study dates
9 Jan 2024to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Active file in oncology department

Who may be able to join

  • The patient will be included if:
  • Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,
  • Is ≥ 18 years of age,
  • Has histologically confirmed colorectal adenocarcinoma,
  • 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,
  • 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]),
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  • Is eligible to surgical procedure,
  • Is fit for the chemotherapy-surgery combination treatment,
  • Is registered in a national health care system (Protection Universelle Maladie [PUMa] included).

Who cannot join

  • The patient will be excluded if:
  • Has definitively unresectable CLRM,
  • Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,
  • Has not resected primary rectal tumor (low and middle),
  • 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,
  • Has no more than two surgical procedures planned for complete resection of primary tumor and/or liver metastases,
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  • Has deficient mismatch repair (dMMR)/ microsatellite instability (MSI) tumors treated with immunotherapy,
  • Blood samples cannot be collected if surgical procedure,
  • Is pregnant or breastfeeding,
  • Cannot be followed-up due to geographical, social, or psychic conditions,
  • Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,
  • Is under guardianship, curatorship, or under the protection of justice.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maximiliano GELLI, MD contact

+33(0)1 40 29 85 00

maximiliano.gelli@gustaveroussy.fr

Marie Line GARCIA, MD contact

+33(0)1 40 29 85 00

marie-line.garcia-larnicol@gercor.com.fr

16 sites in 1 country

France16 sites, 16 recruiting

  • CHU Jean Minjoz

    Besançon

    Christophe BORG, MD

    Not yet recruiting

  • Institut Bergonié

    Bordeaux

    Grégoire DESOLNEUX, MD

    Recruiting

  • CHU Lille - Hôpital Huriez

    Lille

    Stéphanie TRUANT, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Aurélien DUPRE, MD

    Recruiting

  • Hôpital Bichât Claude Bernard

    Paris

    Gaël GOUJON, MD

    Not yet recruiting

  • Hôpital Cochin

    Paris

    David FUKS, MD

    Recruiting

  • Hôpital Pitié Salpêtrière

    Paris

    Claire GOUMARD, MD

    Recruiting

  • Hôpital Saint Antoine

    Paris

    François PAYE, MD

    Recruiting

  • Institut Mutualiste Montsouris

    Paris

    David MLAKA, MD

    Recruiting

  • Hôpital Haut Lévêque

    Pessac

    Denis SMITH, MD

    Recruiting

  • CHU de Poitiers

    Poitiers

    Camille EVRARD, MD

    Recruiting

  • CHU Rouen

    Rouen

    Frédéric FIORE, MD

    Not yet recruiting

  • CHU Strasbourg

    Strasbourg

    Pietro ADDEO, MD

    Recruiting

  • CHRU Tours

    Tours

    Petru BUCUR, MD

    Recruiting

  • Hôpital Paul Brousse

    Villejuif

    René ADAM, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Maximiliano GELLI, MD

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the detailed description

Blood collection times according to specific clinical situations:

  • Standard approach
  • Combined surgery
  • Reverse strategy
  • Two-stage hepatectomy
Medical subject headings
Colorectal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)

    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.

    Measured: Up to 36 months

Secondary outcomes (6)

  1. Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.

    EFS is defined as time between inclusion until the occurrence of an event: disease progression, relapse, disease progression, or death from any reason.

    Measured: Up to 4 years

  2. Overall survival (OS) n patients who undergo curative-intent resection of CRLM.

    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.

    Measured: Up to 4 years

  3. Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.

    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.

    Measured: Up to 4 years

  4. Prognostic value of ctDNA

    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),

    Measured: Up to 4 years

  5. Prognostic factor(s) for disease recurrence and survival.

    Prognostic factor(s) for disease recurrence and survival in patients who undergo curative-intent resection of CRLM.

    Measured: Up to 4 years

  6. Association between ctDNA and clinical features.

    To identify the clinical, biological, and pathological factors associated with the ctDNA level.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start9 Jan 2024
  3. Primary completion25 Sep 2025 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
232 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787197
Sponsor's protocol ID
CLIMES G-118 CIRCULATE-4
Acronym
CLIMES
Status last verified
Jul 2025
First submitted
8 Mar 2023
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Colorectal Cancer and Circulating Tumor DNA, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maximiliano GELLI, MD (+33(0)1 40 29 85 00, maximiliano.gelli@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05787197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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