NCT03841799 COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
| NCT ID | NCT03841799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Leon Berard |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2019-05-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2019-05-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of COLON-IM is to describe colorectal tissue microenvironment (neutrophils infiltrate) of patients with benign or malignant colorectal lesion (from stage I to III according to Tumor Node Metastasis (TNM)/ Union for International Cancer Control (UICC) classification).
Eligibility 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.
Contact & Investigator
Matthieu SARABI, Dr
PRINCIPAL INVESTIGATOR
Centre Leon Berard
Frequently Asked Questions
Who can join the NCT03841799 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03841799 currently recruiting?
Yes, NCT03841799 is actively recruiting participants. Contact the research team at gwenaelle.garin@lyon.unicancer.fr for enrollment information.
Where is the NCT03841799 trial being conducted?
This trial is being conducted at Lyon, France, Lyon, France, Lyon, France.
Who is sponsoring the NCT03841799 clinical trial?
NCT03841799 is sponsored by Centre Leon Berard. The principal investigator is Matthieu SARABI, Dr at Centre Leon Berard. The trial plans to enroll 400 participants.
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