RecruitingNCT03841799

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

COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

Sponsor

Centre Leon Berard

Enrollment

400 participants

Start Date

May 2, 2019

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria5

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.