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Recruiting Observational

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

NCT03841799 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-05-02
Last updated
2026-04-24

Condition(s) studied

Colorectal Cancer

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia. — At surgery
    Rate of immune infiltrate in colorectal tissue

Trial sites (3)

FacilityCityRegionStatus
Hopital Saint Joseph Saint Luc Lyon Lyon Recruiting
Clinique de L'Infirmerie Protestante Lyon France Recruiting
Centre Leon Berard Lyon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03841799 on ClinicalTrials.gov ↗ ← All trials in France