Clinical Trials in France / NCT03841799
Recruiting
Observational
COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
NCT03841799 · tracked via the Priya Life Science France tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Hopital Saint Joseph Saint Luc | Lyon | Lyon | Recruiting |
| Clinique de L'Infirmerie Protestante | Lyon | France | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
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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