Clinical and BIOgical Analyses of RECtal Tumors

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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 outcome measures (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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Centre Léon Bérard — Lyon

Identifiers

NCT: NCT07499921 · ET25-227

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗