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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Inclusion Criteria: - I1. Male or female patient 18 age or older at time of inform consent signature. - I2. Patient 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. - 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia.

Secondary Outcome Measures

Name	Time	Method
Transcriptome profiling by RNAseq of neutrophils associated with neoplastic and preneoplastic lesions.;Characterization of lymphocyte cells infiltrate in colorectal tissue (normal, neoplastic and preneoplastic).;Evaluation of the correlation between immune infiltrate and clinical data, microsatellite status and clinical evolution.;Evaluation of cytokinic environment associated to neoplastic and preneoplastic lesions and evaluation of the correlation between cytokinic environment and clinical data, microsatellite status and clinical evolution.;Identification of microbiota modifications in stools and mucosa during colic carcinogenesis;Identification of potential molecular abnormalities in cancer cells from colorectal tissue and from blood samples.