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
This trial does not accept healthy volunteersQualifiers
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 population
Cohort A : with benign or malignant colorectal lesion (from stage I to III according toTNM/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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia.
Rate of immune infiltrate in colorectal tissue
Time frame
At surgerySecondary outcomes
1
Transcriptome profiling by RNAseq of neutrophils associated with neoplastic and preneoplastic lesions.
mRNA level by RNAseq from neutrophils at different preneoplastic and neoplastic stages.
Time frame
At surgery2
Characterization of lymphocyte cells infiltrate in colorectal tissue (normal, neoplastic and preneoplastic).
Rate of lymphocyte cells in colorectal tissue (normal, neoplastic and preneoplastic).
Time frame
At surgery3
Evaluation of the correlation between immune infiltrate and clinical data, microsatellite status and clinical evolution.
Correlation between immune infiltrate (including neutrophils infiltrate) and clinical data (neoplastic lesion stage according to TNM/UICC classification and preneoplastic lesion (low or high dysplasia), microsatellite status, clinical outcome (survival without relapse and overall survival).
Time frame
At surgery and through study completion, at least 42 months4
Evaluation of cytokinic environment associated to neoplastic and preneoplastic lesions and evaluation of the correlation between cytokinic environment and clinical data, microsatellite status and clinical evolution.
Correlation between cytokinic environment and clinical data (neoplastic lesion stage according to TNM/UICC classification and preneoplastic lesion (low or high dysplasia), microsatellite status, clinical outcome (survival without relapse and overall survival)
Time frame
At surgery and through study completion, at least 42 monthsSponsors and contacts
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Source ClinicalTrials.gov