Colorectal NeoplasmsFORCENCT07871227
Follow-up After Oncological Resection by Endoscopic Colorectal ESD (Endoscopic Submucosal Dissection)
An observational study of Colorectal Neoplasms, run by University Hospital, Bordeaux at 14 sites in France.
Trial summary
Colorectal cancer is a common and leading cause of death. Pre-cancerous lesions, as well as some so-called superficial cancers, can be resected via endoscopy. The technique chosen in the case of extensive lesions or superficial cancer is submucosal dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Surgery, Radiochimiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 14 sitesFrance
- Study dates
- Oct 2026to Dec 2030
- 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: The study population will be drawn from the FECCo registry and will include patients who have undergone endoscopic resection using ESD, with final histological analysis confirming the presence of a colorectal cancer at high risk of lymph node recurrence.
Who may be able to join
- Adult patient (18 years or older).
- Presumed diagnosis of localized superficial colorectal cancer (T1) during endoscopy using the Conecct classification, confirmed by subsequent histopathological analysis.
- Patient included in the French Colorectal ESD Cohort in Experts Centers (FECCo registry) since September 2019 for submucosal dissection.
- Histological analysis of the resection specimen revealing a superficial colorectal adenocarcinoma with high risk of lymphatic recurrence, defined by at least one of the following criteria: submucosal invasion depth ≥ 1000 microns, tumor budding grade ≥ 2, presence of lymphatic and/or vascular emboli.
Who cannot join
- History of Crohn's disease (ICD-10: K50) or ulcerative colitis (ICD-10: K51).
- History of familial adenomatous polyposis and/or genetic predisposition to colorectal cancer (ICD-10: D12.6+0/1/2/4/5 and 6).
- Malignant tumor of the colon staged ≥ T2.
- Patients not included in the FECCo registry.
- Documented objection through the non-opposition form following review of the information notice
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Francois TOQUER contact
14 sites in 1 country
France14 sites
Clinique de l'Anjou
Angers, 49000
Edouard CHABRUN, MD, +33241241580, echabrun@gmail.com
Edouard CHABRUN, MD
CHU Dijon Bourgogne
Dijon, 21079
Thibault DEGAND, MD, +33380293750, thibault.degand@chu-dijon.fr
Thibault DEGAND, MD
CHU de Limoges
Limoges, 87042
Jérémie JACQUES, PROF, +33555058772, jeremie.jacques@chu-limoges.fr
Jérémie JACQUES, PROF
Hospices civils de Lyon - Hôpital Edouard Herriot
Lyon, 69003
Mathieu PIOCHE, PROF, +33472110369, mathieu.pioche@chu-lyon.fr
Mathieu PIOCHE, PROF
Clinique Jean Mermoz
Lyon, 69008
Sarah LEBLANC, MD, +33478756743, sarahleblanc34@hotmail.com
Sarah LEBLANC, MD
Clinique Jules Verne
Nantes, 44300
Bertrand BRIEAU, MD, +33251173400, bertrand.brieau@gmail.com
Bertrand BRIEAU, MD
CHU Nîmes
Nîmes, 30029
Ludovic CAILLO, MD, +33466683183, ludovic.caillo@chu-nimes.fr
Ludovic CAILLO, MD
AP-HP Hôpital Cochin
Paris, 75014
Arthur BELLE, MD, +33158414243, arthur.belle@aphp.fr
Arthur BELLE, MD
Paris Saint Joseph
Paris, 75014
Yann LE BALEUR, MD, +33144123009, ylebaleur@ghpsj.fr
Yann LE BALEUR, MD
AP-HP Hôpital Européen Georges-Pompidou
Paris, 75015
Guillaume PERROD, MD, +33156095700, guillaume.perrod@aphp.fr
Guillaume PERROD, MD
CHU de Bordeaux
Pessac, 33604
Arthur BERGER, MD, +33557656439, arthur.berger@chu-bordeaux.fr
Arthur BERGER, MD
CHU de Rennes
Rennes, 35033
Timothée WALLENHORST, MD, +33299284321, timothee.wallenhorst@chu-rennes.fr
Timothée WALLENHORST, MD
Clinique Santé Atlantique
Saint-Herblain, 44800
Nicolas MUSQUER, MD, +33251724626, drnicolasmusquer@outlook.fr
Nicolas MUSQUER, MD
CHRU de Nancy
Vandœuvre-lès-Nancy, 54511
Marion SCHAEFER, MD, +33383154149, m.schaefer@chru-nancy.fr
Marion SCHAEFER, MD
About this study
Official title: Follow-up After Oncological Resection by Endoscopic Colorectal ESD
Colorectal cancer is a common and leading cause of death. Pre-cancerous lesions, as well as some so-called superficial cancers, can be resected via endoscopy. The technique chosen in the case of extensive lesions or superficial cancer is submucosal dissection. This technique helps avoid surgery, which has a higher morbidity and mortality (especially due to the non-preservation of the organ).
Read the detailed description
French data from over 4,000 dissections (French Colorectal ESD Cohort in Experts Centers, FECCo, Clinical Trial NCT04592003) of LST (Lateral Spreading Tumor) or superficial colorectal cancer show reassuring results in terms of effectiveness with an 88% complete resection rate (R0) and safety with 1.2% of secondary surgery due to complications. Due to the absence of lymph node dissection compared to surgery, there is a theoretical risk of higher lymphatic recurrence with submucosal dissection. This study would allow for a better preoperative assessment of the benefit/risk ratio, as well as a more tailored therapeutic approach afterward based on the course of the resection and the analysis of the surgical specimen.
- Conditions
- Colorectal Neoplasms
- Being tested
- Surgery, Radiochimiotherapy
- Keywords
- Rectal Cancer, Rectum Cancer, Submucosal dissection, Lymph node recurrence, Risk factors
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery, RadiochimiotherapyProcedure or surgery
Analysis of medical data and residual biological samples
| Study group | Role | What they receive |
|---|---|---|
| Surgery, Radiochimiotherapy, Surveillance | Patients who underwent surgery, radiochimiotherapy or nothing. Receives: Procedure: Surgery, Radiochimiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Proportion of patients who remain free of oncological recurrence, either locoregional and/or metastatic, at 12 months after ESD.
Measured: 12 months visit
Secondary outcomes (6)
Post-adjuvant treatment mortality
Proportion of patients who have died from any cause at 1, 2, and 3 years after treatment.
Measured: 12 months, 24 months and 36 months visits
Recurrence-free survival
Compare recurrence-free survival after local excision complicated by intraoperative perforation versus uncomplicated cases.
Measured: 12 months visit
Adherence to oncological follow-up recommendations
Evaluate adherence to oncological follow-up recommendations proposed in multidisciplinary tumor board (MTB) meetings and/or by the operator.
Measured: 12 months visit
Oncological risk factors
Evaluate oncological risk factors for lymph node and/or metastatic recurrence following local excision of a superficial colorectal cancer.
Measured: 12 months visit
Healthcare resource utilization.
Compare healthcare resource utilization.
Measured: at 30 days, 3, 12, 24 and 36 months
New histo-prognostic risk factors
Investigate new histo-prognostic risk factors using molecular biology and proteomic profiling on submucosal dissection specimens.
Measured: 12 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871227
- Sponsor's protocol ID
- CHUBX 2025/094
- Acronym
- FORCE
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up After Oncological Resection by Endoscopic Colorectal ESD
- ClinicalTrials.gov ID
- NCT07871227
- Acronym / sponsor ID
- FORCE / CHUBX 2025/094
- Conditions
- Colorectal Neoplasms
- Keywords
- Rectal Cancer, Rectum Cancer, Submucosal dissection, Lymph node recurrence, Risk factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is a common and leading cause of death. Pre-cancerous lesions, as well as some so-called superficial cancers, can be resected via endoscopy. The technique chosen in the case of extensive lesions or superficial cancer is submucosal dissection. This technique helps avoid surgery, which has a higher morbidity and mortality (especially due to the non-preservation of the organ).
Detailed description
French data from over 4,000 dissections (French Colorectal ESD Cohort in Experts Centers, FECCo, Clinical Trial NCT04592003) of LST (Lateral Spreading Tumor) or superficial colorectal cancer show reassuring results in terms of effectiveness with an 88% complete resection rate (R0) and safety with 1.2% of secondary surgery due to complications. Due to the absence of lymph node dissection compared to surgery, there is a theoretical risk of higher lymphatic recurrence with submucosal dissection. This study would allow for a better preoperative assessment of the benefit/risk ratio, as well as a more tailored therapeutic approach afterward based on the course of the resection and the analysis of the surgical specimen.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery, Radiochimiotherapy, Surveillance | – | Procedure: Surgery, RadiochimiotherapyPatients who underwent surgery, radiochimiotherapy or nothing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be drawn from the FECCo registry and will include patients who have undergone endoscopic resection using ESD, with final histological analysis confirming the presence of a colorectal cancer at high risk of lymph node recurrence.
Key inclusion criteria (4 listed)
- Adult patient (18 years or older).
- Presumed diagnosis of localized superficial colorectal cancer (T1) during endoscopy using the Conecct classification, confirmed by subsequent histopathological analysis.
- Patient included in the French Colorectal ESD Cohort in Experts Centers (FECCo registry) since September 2019 for submucosal dissection.
- Histological analysis of the resection specimen revealing a superficial colorectal adenocarcinoma with high risk of lymphatic recurrence, defined by at least one of the following criteria: submucosal invasion depth ≥ 1000 microns, tumor budding grade ≥ 2, presence of lymphatic and/or vascular emboli.
Key exclusion criteria (5 listed)
- History of Crohn's disease (ICD-10: K50) or ulcerative colitis (ICD-10: K51).
- History of familial adenomatous polyposis and/or genetic predisposition to colorectal cancer (ICD-10: D12.6+0/1/2/4/5 and 6).
- Malignant tumor of the colon staged ≥ T2.
- Patients not included in the FECCo registry.
- Documented objection through the non-opposition form following review of the information notice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery, RadiochimiotherapyAnalysis of medical data and residual biological samples | Procedure or surgery | Surgery, Radiochimiotherapy, Surveillance |
Primary outcome
Recurrence-free survival
Time frame: 12 months visit
Proportion of patients who remain free of oncological recurrence, either locoregional and/or metastatic, at 12 months after ESD.
6 secondary outcomes
Post-adjuvant treatment mortality
Time frame: 12 months, 24 months and 36 months visits
Recurrence-free survival
Time frame: 12 months visit
Adherence to oncological follow-up recommendations
Time frame: 12 months visit
Oncological risk factors
Time frame: 12 months visit
Healthcare resource utilization.
Time frame: at 30 days, 3, 12, 24 and 36 months
New histo-prognostic risk factors
Time frame: 12 months visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francois TOQUER contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by University Hospital, Bordeaux at 14 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 5 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 Arthur BERGER, MD (+335 56 79 56 79, arthur.berger@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: 12 months visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.