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
- Diseases
- Colorectal cancer
- 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
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Saint Joseph Saint Luc Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Clinique de L'Infirmerie Protestante Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.