Rectal CancerBIORECNCT07499921
Clinical and BIOgical Analyses of RECtal Tumors
A study testing Blood sample collection, Tumor Samples and Healthy tissue sample in people with Rectal Cancer, run by Centre Leon Berard at 1 site in France.
Trial summary
Rectal cancer is a common cancer with an incidence of approximately 14,000 new cases per year in France. The survival rate is approximately 50% at 5 years, ranging from 90% for patients with localized rectal cancer to 18% for patients with metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Blood sample collection, Tumor Samples and Healthy tissue sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2026to 1 May 2033
- Phase
- Interventional
- 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
Who may be able to join
- Male or female aged 18 or over
- Patients who have undergone surgery for rectal cancer since January 1st, 2019
- Histological diagnosis of rectal adenocarcinoma confirmed on a surgical sample
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucas DE CRIGNIS, MD contact
France1 site
Centre Léon Bérard
Lyon
Philippe CASSIER, MD, (+33)4 26 55 68 33, philippe.cassier@lyon.unicancer.fr
Lucas DE CRIGNIS, MD, lucas.decrignis@lyon.unicancer.fr
About this study
Rectal cancer is a common cancer with an incidence of approximately 14,000 new cases per year in France. The survival rate is approximately 50% at 5 years, ranging from 90% for patients with localized rectal cancer to 18% for patients with metastases.
Surgery with local or complete exicion is the standard treatment for early stages. The implementation of Total Neoadjuvant Therapy (TNT) for locally advanced stages has led to a significant improvement in the prognosis for rectal cancer. The complete pathological response rate of aproximately 20% after TNT has led to the "Watch and Wait" strategy, which aims to avoid surgery and preserve the rectum, but there is currently no reliable method for identifying responders. Rectal tumors with mismatch repair defiency (MMRd) and/or High microsatellite instability (MSI-H) are considered resistant to neoadjuvant chemotherapy, but those patients can benefit from immunotherapy treatment. Identifying patients who will respond to immunotherapy is crucial for this type of treatment. Pre-existing immune infiltration within the tumor microenvironnement prior to any treatment is an important prognostic factor and could help predict response to immunotherapy, as well as neoadjuvant treatment. Studying the immune microenvironnement and how it changes during different treatments could therefore help identify responders for whom treatment without surgery could be considered in order to avoid the deterioration in quality of life often associated with this procedure in this type of cancer. Finally, analysis of residual tumor cells after chemotherapy and/or chemoradiotherapy could help identify possible mechanisms of resistance to current treatments and develop strategies to counter them.
- Conditions
- Rectal Cancer
- Being tested
- Blood sample collection, Tumor Samples, Healthy tissue sample
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionProcedure or surgery
Blood sample will be collected during a visit scheduled as part of the standard care for the patient
Tumor SamplesProcedure or surgery
Archival FFPE (Formalin-Fixed Paraffin-Embedded) or Fresh Frozen tumor samples from initial diagnosis, surgery, and metastases in case of relapse will be collected if available.
Healthy tissue sampleProcedure or surgery
A healthy tissue sample from the surgical site (excision margin) of the primary tumor or from an additionnal sample taken during preoperative rectosigmoidoscopy performed as part of the standard care will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019 | Experimental | Not described Receives: Procedure: Blood sample collection; Procedure: Tumor Samples; Procedure: Healthy tissue sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a correlation between biological data and clinical data of patients with rectal tumors
Measured: Until up to 3 years follow-up of the last patient enrolled
Secondary outcomes (2)
Comparison of stroma of tumor samples from : 1) primary tumors operated after preoperative chemotherapy, 2) biopsies performed before chemotherapy and 3) primary tumors operated without preoperative treatment
Measured: Until up to 3 years follow-up of the last patient enrolled
Comparision of healthy tissue, stroma of primary tumors samples and metastases in patients for whom samples of primary tumor and metastases will be available.
Measured: Until up to 3 years follow-up of the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical-biological cohort
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499921
- Sponsor's protocol ID
- ET25-227
- Acronym
- BIOREC
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and BIOgical Analyses of RECtal Tumors
- ClinicalTrials.gov ID
- NCT07499921
- Acronym / sponsor ID
- BIOREC / ET25-227
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2033 (estimated)
- First posted
- 30 Mar 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.
Rectal cancer is a common cancer with an incidence of approximately 14,000 new cases per year in France. The survival rate is approximately 50% at 5 years, ranging from 90% for patients with localized rectal cancer to 18% for patients with metastases.
Surgery with local or complete exicion is the standard treatment for early stages. The implementation of Total Neoadjuvant Therapy (TNT) for locally advanced stages has led to a significant improvement in the prognosis for rectal cancer. The complete pathological response rate of aproximately 20% after TNT has led to the "Watch and Wait" strategy, which aims to avoid surgery and preserve the rectum, but there is currently no reliable method for identifying responders. Rectal tumors with mismatch repair defiency (MMRd) and/or High microsatellite instability (MSI-H) are considered resistant to neoadjuvant chemotherapy, but those patients can benefit from immunotherapy treatment. Identifying patients who will respond to immunotherapy is crucial for this type of treatment. Pre-existing immune infiltration within the tumor microenvironnement prior to any treatment is an important prognostic factor and could help predict response to immunotherapy, as well as neoadjuvant treatment. Studying the immune microenvironnement and how it changes during different treatments could therefore help identify responders for whom treatment without surgery could be considered in order to avoid the deterioration in quality of life often associated with this procedure in this type of cancer. Finally, analysis of residual tumor cells after chemotherapy and/or chemoradiotherapy could help identify possible mechanisms of resistance to current treatments and develop strategies to counter them.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical-biological cohort
| Arm | Type | Receives |
|---|---|---|
| Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019 | Experimental | Procedure: Blood sample collection, Procedure: Tumor Samples, Procedure: Healthy tissue sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 or over
- Patients who have undergone surgery for rectal cancer since January 1st, 2019
- Histological diagnosis of rectal adenocarcinoma confirmed on a surgical sample
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Blood sample collectionBlood sample will be collected during a visit scheduled as part of the standard care for the patient | Procedure or surgery | Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019 |
| Tumor SamplesArchival FFPE (Formalin-Fixed Paraffin-Embedded) or Fresh Frozen tumor samples from initial diagnosis, surgery, and metastases in case of relapse will be collected if available. | Procedure or surgery | Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019 |
| Healthy tissue sampleA healthy tissue sample from the surgical site (excision margin) of the primary tumor or from an additionnal sample taken during preoperative rectosigmoidoscopy performed as part of the standard care will be collected. | Procedure or surgery | Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019 |
Primary outcome
Establish a correlation between biological data and clinical data of patients with rectal tumors
Time frame: Until up to 3 years follow-up of the last patient enrolled
2 secondary outcomes
Comparison of stroma of tumor samples from : 1) primary tumors operated after preoperative chemotherapy, 2) biopsies performed before chemotherapy and 3) primary tumors operated without preoperative treatment
Time frame: Until up to 3 years follow-up of the last patient enrolled
Comparision of healthy tissue, stroma of primary tumors samples and metastases in patients for whom samples of primary tumor and metastases will be available.
Time frame: Until up to 3 years follow-up of the last patient enrolled
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 30 Apr 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.
Lucas DE CRIGNIS, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection, Tumor Samples and Healthy tissue sample in people with Rectal Cancer, run by Centre Leon Berard at 1 site 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 3 inclusion and 1 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Philippe CASSIER, MD ((+33)04 26 55 68 33, philippe.cassier@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a correlation between biological data and clinical data of patients with rectal tumors (time frame: Until up to 3 years follow-up of the last patient enrolled). 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 30 Apr 2026.