COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

NCT03841799 | Recruiting

• 1 other identifier: ET18-276 (COLON-IM)
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

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 Tumor Node Metastasis (TNM)/ Union for International Cancer Control (UICC) classification).

Conditions

Colorectal Cancer

Keywords

Microbiota; Microenvironment colorectal tissue; Immune infiltrate

Outcome Measures

Primary Outcomes (1)

• Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia.

  Rate of immune infiltrate in colorectal tissue

  At surgery

Secondary Outcomes (6)

• Transcriptome profiling by RNAseq of neutrophils associated with neoplastic and preneoplastic lesions.

  At surgery

• Characterization of lymphocyte cells infiltrate in colorectal tissue (normal, neoplastic and preneoplastic).

  At surgery

• Evaluation of the correlation between immune infiltrate and clinical data, microsatellite status and clinical evolution.

  At surgery and through study completion, at least 42 months

• 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.

  At surgery and through study completion, at least 42 months

• Identification of microbiota modifications in stools and mucosa during colic carcinogenesis

  At surgery, at Month 6 post-surgery, at Month 9 post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• E1. Pregnant or breast-feeding female patient.
• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (3)

Hopital Saint Joseph Saint Luc

Lyon, Lyon, 69007, France

RECRUITING

Clinique de L'Infirmerie Protestante

Lyon, 69004, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample at surgery (no additional needle-sticks). Stool samples at surgery, at Month 3 post surgery and at Month 6 post surgery. Colorectal tissue sample from surgical specimen (healthy tissue, polyp(s), colorectal tumor).

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Matthieu SARABI, Dr

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwenaelle GARIN

CONTACT

04 26 55 68 24; gwenaelle.garin@lyon.unicancer.fr

Matthieu SARABI, Dr

CONTACT

04 69 85 75 82; matthieu.sarabi@lyon.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 15, 2019
• Study Start: May 2, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

FR (3)