Examining the role of microbiota and immune cells in colorectal tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COLON-IM study aims to analyze the microenvironment of colorectal tissue in patients with benign or malignant lesions, focusing on immune cell infiltration and microbiota profiles. It includes patients with colorectal cancer at various stages, specifically those eligible for surgery and not previously treated with systemic anticancer agents. The study seeks to understand how these factors contribute to colorectal carcinogenesis and the potential implications for immunotherapy responses. By characterizing the immune context and microbiota, the research hopes to identify new immune checkpoints for targeted therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* I1. Male or female patient 18 age or older at time of inform consent signature.
* I2. Patient Cohort A : with benign or malignant colorectal lesion (from stage I to III according to TNM/UICC classification) eligible to surgery, not previously be treated with an anticancer systemic agent (any type) and not be previously exposed to radiotherapy.

Cohort B : with localised colon/rectume adenocarcinoma, eligible to surgery, and treated by radiotherapy and/or pre-operative chemotherapy

* I3. Patient should be able and willing to comply with procedures as per protocol.
* I4. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.
* I5. Patient must be covered by a medical insurance.

Exclusion Criteria:

* E1. Pregnant or breast-feeding female patient.
* E2. Prior treatment with : Any immunomodulatory treatment (streroids, immunosuppressive therapies) within 4 weeks prior inclusion, Any antibiotics within 8 weeks prior inclusion.
* E3. Patients with secondary malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints and is approved by the sponsor. Examples of the latter include: in-situ carcinoma of the cervix treated adequately, basal or squamous cell carcinoma of the skin. Patients previously treated for another cancer type and without evidence of relapse for at least 1 year are eligible.
* E4. Patient with inflammatory disease or autoimmune disease.
* E5. Patient under curatorship, guardianship or judicial protection.

Where it's running

• Hopital Saint Joseph Saint Luc
  Lyon, Lyon, France Recruiting
• Clinique de L'Infirmerie Protestante
  Lyon, France Recruiting
• Centre Leon Berard
  Lyon, France Recruiting

Study contacts

• Principal investigator: Matthieu SARABI, Dr — Centre Leon Berard
• Study coordinator: Gwenaelle GARIN
• Email: gwenaelle.garin@lyon.unicancer.fr
• Phone: 04 26 55 68 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.