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COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
RECRUITINGSponsored by Centre Leon Berard
Actively Recruiting
SponsorCentre Leon Berard
Started2019-05-02
Est. completion2027-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03841799
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
CancerColorectal Cancer
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Actively Recruiting
SponsorCentre Leon Berard
Started2019-05-02
Est. completion2027-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03841799