Examining the role of microbiota and immune cells in colorectal tissue
COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
This study is trying to understand how the bacteria and immune cells in the colon affect the development of colorectal cancer in patients who are about to have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 3 sites (Lyon, Lyon and 2 other locations) |
| Trial ID | NCT03841799 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with benign or malignant colorectal lesions eligible for surgery.
Not a fit: Patients who have received prior immunomodulatory treatments or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of colorectal cancer mechanisms and enhance immunotherapy strategies for patients.
How similar studies have performed: While the role of microbiota in cancer is being explored, this specific approach to understanding immune infiltrate in colorectal tissue is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lyon, Lyon and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.