COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

Recruiting now

Conditions studied: Colorectal Cancer

In brief

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).

Key facts

Study ID

NCT03841799

Run by

Centre Leon Berard

People needed

400

Starts

2019-05-02

Expected to finish

2029-12-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Hopital Saint Joseph Saint Luc — Lyon, Lyon, France (enrolling)
• Clinique de L'Infirmerie Protestante — Lyon, France (enrolling)
• Centre Leon Berard — Lyon, France (enrolling)

Full record on ClinicalTrials.gov

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