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NCT Number: NCT07499921

Clinical and BIOgical Analyses of RECtal Tumors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not applicable

Treatment and study plan

blood sample collection

Procedure

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

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lucas DE CRIGNIS, MD

CONTACT

[email protected]

Philippe CASSIER, MD

CONTACT

[email protected]

(+33)04 26 55 68 33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: BIOREC

Important dates

Study start
2026
Primary completion
2030
Study completion
2033
First posted
Mar 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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