An observational study in Colorectal Neoplasms, Precancerous Conditions and Adenocarcinoma of the Colon, sponsored by University Hospital, Montpellier. Not yet recruiting at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University Hospital, Montpellier · Observational
Among 581 studies in Colorectal Neoplasms with a site in France — 110 open to participants now, 165 under way, 26 of them phase 3. Colorectal Neoplasms · France.
Among the 581 studies in Colorectal Neoplasms with a site in France, this one is the 13th largest by planned enrollment of the 102 observational ones, is one of 19 that started in 2026, is one of 102 observational ones, reaches primary completion later than 138 of the 164 other live ones, and was the 565th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →110 of the 581 studies in Colorectal Neoplasms with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →581 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 19 started in 2026.
Median enrollment 152 across the 463 interventional studies, 278 across the 102 observational. Of the 356 that completed or were terminated, 105 (29%) have results posted.
223 of 581 have an industry lead sponsor. The 10 most frequent:
University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
University Hospital, Montpellier has 6 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
39 of the studies in Colorectal Neoplasms with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07520578Phase 3University Hospital, CaenEFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST. (SUIVICOLO) | 2027-03-24 |
| NCT05720910Institut BergoniéStreamlined Geriatric and Oncological Evaluation Based On IC Technology | 2026-11-05 |
| NCT07361575Clinique Paris-BercyStudy Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG). | 2026-11-15 |
| NCT07116668SafeHeal IncSafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study | 2026-12 |
| NCT07151040One-carbon Therapeutics ABPhase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors | 2026-12 |
Among the 581 studies in Colorectal Neoplasms with a site in France, from their registry updates:
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Blood sample
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.
Time frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
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.
Time frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
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.
Time frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
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.
Time frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
Plan to share: No
Start is estimated for Jun 2026; primary completion for Mar 2029, 33 months later.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 33 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier →