Colorectal Cancer Clinical Trial
Official title:
COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
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).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 2026 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Leon Berard | Lyon | |
France | GARBIT Vincent | Lyon |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia. | Rate of immune infiltrate in colorectal tissue | At surgery | |
Secondary | Transcriptome profiling by RNAseq of neutrophils associated with neoplastic and preneoplastic lesions. | mRNA level by RNAseq from neutrophils at different preneoplastic and neoplastic stages. | At surgery | |
Secondary | Characterization of lymphocyte cells infiltrate in colorectal tissue (normal, neoplastic and preneoplastic). | Rate of lymphocyte cells in colorectal tissue (normal, neoplastic and preneoplastic). | At surgery | |
Secondary | Evaluation of the correlation between immune infiltrate and clinical data, microsatellite status and clinical evolution. | Correlation between immune infiltrate (including neutrophils infiltrate) and clinical data (neoplastic lesion stage according to TNM/UICC classification and preneoplastic lesion (low or high dysplasia), microsatellite status, clinical outcome (survival without relapse and overall survival). | At surgery and through study completion, at least 42 months | |
Secondary | 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. | Correlation between cytokinic environment and clinical data (neoplastic lesion stage according to TNM/UICC classification and preneoplastic lesion (low or high dysplasia), microsatellite status, clinical outcome (survival without relapse and overall survival) | At surgery and through study completion, at least 42 months | |
Secondary | Identification of microbiota modifications in stools and mucosa during colic carcinogenesis | Sequences of the variable portions of the 16s ribosomal RNA gene | At surgery, at Month 6 post-surgery, at Month 9 post-surgery | |
Secondary | Identification of potential molecular abnormalities in cancer cells from colorectal tissue and from blood samples. | Circulating tumor DNA and tumor DNA. | At surgery |
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