Clinical and BIOgical Analyses of RECtal Tumors

NCT07499921 | Not Yet Recruiting

• 1 other identifier: ET25-227
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Establish a correlation between biological data and clinical data of patients with rectal tumors

  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

  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.

  Until up to 3 years follow-up of the last patient enrolled

Study Arms (1)

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

Interventions

Blood sample collection PROCEDURE

Blood sample will be collected during a visit scheduled as part of the standard care for the patient

Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019

Tumor Samples PROCEDURE

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.

Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019

Healthy tissue sample PROCEDURE

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.

Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Philippe CASSIER, MD

CONTACT

(+33)04 26 55 68 33; philippe.cassier@lyon.unicancer.fr

Lucas DE CRIGNIS, MD

CONTACT

lucas.decrignis@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical-biological cohort

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2033
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)