COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Leon Berard
About this trial
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 criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov