Status:
RECRUITING
COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
Lead Sponsor:
Centre Leon Berard
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief 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 Tu...
Detailed Description
Colorectal cancers (CRC) are the most common gastrointestinal cancers in Western countries (both Europe and the US) ; they are both associated with significant morbidity and mortality. The 5-year surv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03841799
Start Date
May 2 2019
End Date
December 1 2029
Last Update
May 25 2025
Active Locations (3)
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1
Hopital Saint Joseph Saint Luc
Lyon, Lyon, France, 69007
2
Clinique de L'Infirmerie Protestante
Lyon, France, 69004
3
Centre Leon Berard
Lyon, France, 69008