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NCT03841799Recruiting

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

COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

Source: ClinicalTrials.gov · Last updated 24 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
8 Feb 2019
Start date
2 May 2019
Primary completion date
Dec 2027
Lead sponsor
Centre Leon Berard
NCT number
NCT03841799

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 2 May 2019 to the primary completion date, Dec 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • E4. Patient with inflammatory disease or autoimmune disease.

Other

  • E1. Pregnant or breast-feeding female patient.
  • E5. Patient under curatorship, guardianship or judicial protection.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hôpital Saint Joseph Saint Luc
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Clinique de L'Infirmerie Protestante
Coordinator of this site? Confirm its status
LyonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.