NCT07499921

Clinical and BIOgical Analyses of RECtal Tumors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Blood sample collection	Blood sample will be collected during a visit scheduled as part of the standard care for the patient
PROCEDURE	Tumor Samples	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.
PROCEDURE	Healthy tissue sample	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-05-01
• Completion: 2033-05-01
• First posted: 2026-03-30
• Last updated: 2026-04-03

Locations

1 site across 1 country: France