COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
About this study
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).
- Condition
- Colorectal Cancer
- Sponsor
- Centre Leon Berard
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Colorectal Cancer
- 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 7
- 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.
- 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.
Where
3 sites, 3 recruiting
Hopital Saint Joseph Saint Luc
Lyon, Lyon, France
Clinique de L'Infirmerie Protestante
Lyon, France
Centre Leon Berard
Lyon, France
Contact
-
Gwenaelle GARIN
04 26 55 68 24 gwenaelle.garin@lyon.unicancer.fr
-
Matthieu SARABI, Dr
04 69 85 75 82 matthieu.sarabi@lyon.unicancer.fr
Potential match only. Final eligibility is determined by the study team.