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Colorectal NeoplasmsFECCO-BioBankNCT07319104

Liquid Biopsy in Early Colorectal Lesions

An observational study of Colorectal Neoplasms and Precancerous Conditions, run by University Hospital, Montpellier at 12 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Early colorectal cancer screening increasingly detects small superficial colonic lesions, but current diagnostic tools still struggle to distinguish benign from malignant lesions and to assess lymph node risk. As histology after resection has limited accuracy, many patients undergo unnecessary surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Venous blood sampling
How many people
1,000 participants
Where
12 sitesFrance
Study dates
15 Jun 2026to 15 Dec 2031
How long will I take part?
3 Months
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: Eligible patients will be identified and recruited in gastroenterology consultations, within the investigating centers to which they will be referred as part of routine care.

Who may be able to join

  • Patient of legal age (≥ 18 years)
  • Patient with a superficial colonic tumor refered for submucosal dissection
  • Patient included in the FECCo cohort (patients will be included concomitantly in FECCO-Biobank)
  • Patient wishing to participate in the FECCO-BioBank biological collection

Who cannot join

  • Person with significant comorbidities preventing blood sampling
  • Patients with a distant metastasis detected by imaging
  • Person unable to read and write French
  • Person who have expressed their opposition to participating in this research after being informed by an investigator and having read the information sheet
  • Person not benefiting from a national health insurance scheme
  • Person under legal protection, guardianship or curatorship
  • Person participating in other study with an ongoing exclusion period

Trial locations and contacts

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

Catherine PANABIERES, MD, PhD contact

c-panabieres@chu-montpellier.fr

12 sites in 1 country

France12 sites
  • University Hospital of Amiens

    Amiens, 80054

    Clara YZET, MD, yzet.clara@chu-amiens.fr

  • University Hospital of Bordeaux

    Bordeaux, 33604

    Arthur BERGER, MD, arthur.berger@chu-bordeaux.fr

  • University Hospital of Brest

    Brest, 29200

    Lucille QUENEHERVE, MD, lucille.queneherve@chu-brest.fr

  • University Hospital of Dijon

    Dijon, 21079

    Thibault DEGAND, MD, thibault.degand@chu-dijon.fr

  • University Hospital of Limoges

    Limoges, 87042

    Jeremy JACQUES, MD, PhD, jeremie.jacques@chu-limoges.fr

  • Civil Hospices of Lyon

    Lyon, 69003

    Mathieu PIOCHE, MD, PhD, mathieu.pioche@chu-lyon.fr

  • Jean Mermoy Private Hospital

    Lyon, 69008

    Sarah LEBLANC, MD, sarahleblanc34@hotmail.com

  • University Hospital of Montpellier

    Montpellier, 34095

    Antoine DEBOURDEAU, MD, a-debourdeau@chu-montpellier.fr

  • University Hospital of Nancy

    Nancy, 54511

    SCHAEFFER Marion, MD, M.SCHAEFER@chru-nancy.fr

  • University Hospital of Nîmes

    Nîmes, 30029

    Ludovic CAILLO, MD, ludovic.caillo@chu-nimes.fr

  • Saint Joseph Hospital

    Paris, 75014

    Yann LE BALEUR, MD, ylebaleur@ghpsj.fr

  • University Hospital of Rennes

    Rennes, 35033

    Timothée WALLENHORST, MD, Timothee.WALLENHORST@chu-rennes.fr

Other trials in France

About this study

Official title: Biobank for Validating Liquid Biopsy in Predicting the Prognosis of Superficial Colonic Lesions

Early colorectal cancer screening increasingly detects small superficial colonic lesions, but current diagnostic tools still struggle to distinguish benign from malignant lesions and to assess lymph node risk. As histology after resection has limited accuracy, many patients undergo unnecessary surgery.

Liquid biopsy, analyzing circulating biomarkers such as tumor DNA, extracellular vesicles, and nucleosomes, offers a non-invasive way to better classify these lesions. Emerging evidence suggests it may outperform current criteria for predicting lymph node involvement in T1 colorectal cancer.

This study will establish a biobank of 1,000 patients to identify blood-based signatures that predict tumor stage and lymph node status. The hypothesis of the study is that circulating biomarkers can accurately differentiate benign from malignant lesions and identify patients with or without lymph node metastasis.

Read the detailed description

Introduction :

Early colorectal cancer screening increasingly identifies superficial colonic lesions, but current diagnostic tools often fail to accurately distinguish benign from malignant lesions or to predict lymph node involvement. As histological criteria have limited predictive value, many patients with T1 tumors undergo unnecessary surgery. Liquid biopsy, based on circulating blood biomarkers, offers a promising non-invasive alternative that may improve diagnostic precision.

Aim :

The study aims to build a biobank of 1,000 patients with superficial colonic tumors to identify and validate circulating biomarker signatures capable of predicting tumor malignancy and lymph node status. The hypothesis is that liquid biopsy markers can reliably differentiate benign from malignant lesions and identify patients at risk of lymph node metastasis.

Methods :

This is a multicenter prospective cohort study embedded in the FECCo cohort. Blood samples will be collected at the time of endoscopic resection and, for pT1 lesions, again 2-6 weeks later. Clinical data will be retrieved annually from the FECCo database. Diagnostic performance of circulating biomarkers will be assessed using ROC curves, logistic regression (Lasso), and bootstrap validation to identify signatures associated with malignancy and lymph node involvement.

Being tested
Venous blood sampling
Keywords
Lymphatic Metastasis, Endoscopy, Gastrointestinal, Liquid Biopsy, Biomarkers, Biobanking
Medical subject headings
Colorectal Neoplasms, Precancerous Conditions, Colonic Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venous blood samplingOther

    Also called Blood sample

    Five 6-7 ml EDTA tubes of venous blood will be collected at two points during the care pathway:

    • Immediately before the endoscopic procedure, at the time of catheter insertion for general anesthesia. This is to study the signal intensity at a baseline stage.
    • Between 2 and 6 weeks after submucosal dissection (only in cases of pT1 adenocarcinoma) and before any further surgery for pT1 cancer. This is to study the presence or absence of a residual signal after local resection.

What is being measured

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

  1. Extracellular vesicles (EVs)

    Detection of plasma extracellular vesicles (EVs):

    • to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)
    • to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.

    Measured: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Secondary outcomes (3)
  1. Circulating nucleosomes

    Detection of circulating nucleosomes:

    • to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)
    • to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.

    Measured: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

  2. Circulating tumor DNA (ctDNA)

    Detection of ctDNA:

    • to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)
    • to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.

    Measured: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

  3. Circulating proteomic profile via O-link technology

    Detection of circulating proteomic profile via O-link technology:

    • to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)
    • to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.

    Measured: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Timeline

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

  1. First posted6 Jan 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion15 Mar 2029 (estimated)
  4. Study completion15 Dec 2031 (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
1,000 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319104
Sponsor's protocol ID
RECHMPL25_0092
Other IDs
2025-A02328-41
Acronym
FECCO-BioBank
Status last verified
May 2026
First submitted
2 Dec 2025
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lecomte T, Tougeron D, Chautard R, Bressand D, Bibeau F, Blanc B, Cohen R, Jacques J, Lagasse JP, Laurent-Puig P, Lepage C, Lucidarme O, Martin-Babau J, Panis Y, Portales F, Taieb J, Aparicio T, Bouche O; Thesaurus National de Cancerologie Digestive (TNCD); Societe Nationale Francaise de Gastroenterologie (SNFGE); Federation Francophone de Cancerologie Digestive (FFCD); Groupe Cooperateur multidisciplinaire en Oncologie (GERCOR); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Societe Francaise de Chirurgie Digestive (SFCD); Societe Francaise d'Endoscopie Digestive (SFED); Societe Francaise de Radiotherapie Oncologique (SFRO); Association de Chirurgie Hepato-Bilio-Pancreatique et Transplantation (ACHBT); Societe Francaise de Pathologie (SFP); Association Francaise pour l'Etude du Foie (AFEF); Societe Francaise de Radiologie (SFR). Non-metastatic colon cancer: French Intergroup Clinical Practice Guidelines for diagnosis, treatments, and follow-up (TNCD, SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, SFP, AFEF, and SFR). Dig Liver Dis. 2024 May;56(5):756-769. doi: 10.1016/j.dld.2024.01.208. Epub 2024 Feb 20.

    PubMed 38383162
  • Zwager LW, Bastiaansen BAJ, Montazeri NSM, Hompes R, Barresi V, Ichimasa K, Kawachi H, Machado I, Masaki T, Sheng W, Tanaka S, Togashi K, Yasue C, Fockens P, Moons LMG, Dekker E. Deep Submucosal Invasion Is Not an Independent Risk Factor for Lymph Node Metastasis in T1 Colorectal Cancer: A Meta-Analysis. Gastroenterology. 2022 Jul;163(1):174-189. doi: 10.1053/j.gastro.2022.04.010. Epub 2022 Apr 15.

    PubMed 35436498
  • Alix-Panabieres C, Pantel K. Liquid Biopsy: From Discovery to Clinical Application. Cancer Discov. 2021 Apr;11(4):858-873. doi: 10.1158/2159-8290.CD-20-1311.

    PubMed 33811121
  • Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.

    PubMed 38477985
  • Wada Y, Shimada M, Murano T, Takamaru H, Morine Y, Ikemoto T, Saito Y, Balaguer F, Bujanda L, Pellise M, Kato K, Saito Y, Ikematsu H, Goel A. A Liquid Biopsy Assay for Noninvasive Identification of Lymph Node Metastases in T1 Colorectal Cancer. Gastroenterology. 2021 Jul;161(1):151-162.e1. doi: 10.1053/j.gastro.2021.03.062. Epub 2021 Apr 2.

    PubMed 33819484
  • Miyazaki K, Wada Y, Okuno K, Murano T, Morine Y, Ikemoto T, Saito Y, Ikematsu H, Kinugasa Y, Shimada M, Goel A. An exosome-based liquid biopsy signature for pre-operative identification of lymph node metastasis in patients with pathological high-risk T1 colorectal cancer. Mol Cancer. 2023 Jan 6;22(1):2. doi: 10.1186/s12943-022-01685-8.

    PubMed 36609320
  • Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Flejou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5. doi: 10.1136/gut.47.2.251.

    PubMed 10896917

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Neoplasms and Precancerous Conditions, run by University Hospital, Montpellier at 12 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 Antoine DEBOURDEAU, MD (+334.67.33.07.83, a-debourdeau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extracellular vesicles (EVs) (time frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)). 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 NCT07319104, which also lists 7 linked publications.

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 2 Jun 2026.

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