- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03841799
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
Study Overview
Status
Conditions
Detailed Description
Colorectal cancers (CRC) are the most common gastrointestinal cancers in Western countries (both Europe and the US) ; they are both associated with significant morbidity and mortality. The 5-year survival is around 63.5% (including all stages). Sporadic colon cancers make up 85% of all colorectal adenocarcinoma. Preneoplastic lesions accumulate alterations in genes that regulate cell growth.
Patients suffering from CRC have a modified intestinal flora compared to healthy people. A specified microbiota profiled combined to genetic and immunological characteristics should be involved in colorectal carcinogenesis. Recent data have showed that responses to immunotherapies are associated with presence of certain bacteria in intestinal flora which potentially boost immune antitumor response.
Immunotherapy is highly efficient in tumors with high mutation load and Microsatellite Instability-High (MSI-H). MSI-H tumors represent 15% of local colorectal tumors. Today, it is important to understand all immune agents roles in colorectal carcinogenesis in order to describe new interesting immune checkpoints to target.
Tumor cells and tissues can escape immune surveillance and immune defense by several mechanisms. All immune cells subtypes present in the tumor, at the invasive tumor front and/or in tertiary lymphoid structures constitute the "immune context". The immune microenvironment has been shown to play a crucial role in disease progression, maintenance and resistance to therapy. All immune cells could play a pro-tumor or an anti-tumor role. For example, lymphocyte infiltrate is described as a prognostic factor in colorectal cancer : a tool (Immunoscore) has been validated as prognostic tool and it provides independent and superior prognostic value to TNM classification. This immune classification measures the host immune response at the tumor site and helps to guide treatment strategies.
Adaptative immunity is well known ; however, innate immunity should also play an early role during carcinogenesis. Role of neutrophils in the tumor microenvironment remains controversial, with evidence for both pro- and anti-tumor roles.Tumour-associated neutrophils (TANS) have an antitumorigenic in early stage of carcinogenesis or a protumorigenic functions in metastatic stage. Evidences indicate that neutrophils manifest functional plasticity during oncogenic process. Neutrophil-to-lymphocyte ratio is associated with patient prognosis ; a high ratio seems to be associated with poor prognostic.
Intestinal microbiota and immune infiltrate play key roles in colorectal microenvironment. Their interdependent interaction and their impacts on colorectal neoplasia and treatments are not well known. The primary objective of COLON-IM is to describe colorectal tissue microenvironment of patients with benign or malignant colorectal lesion (from stage I to III according to TNM/UICC classification).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Gwenaelle GARIN
- Phone Number: 04 26 55 68 24
- Email: gwenaelle.garin@lyon.unicancer.fr
Study Contact Backup
- Name: Matthieu SARABI, Dr
- Phone Number: 04 69 85 75 82
- Email: matthieu.sarabi@lyon.unicancer.fr
Study Locations
-
-
-
Lyon, France, 69008
- Recruiting
- Centre Leon Berard
-
Contact:
- Lucas DE CRIGNIS, Dr
- Phone Number: 04 78 78 28 28
- Email: Lucas.decrignis@lyon.unicancer.fr@lyon.unicancer.fr
-
Lyon, France, 69004
- Not yet recruiting
- GARBIT Vincent
-
Contact:
- GARBIT Vincent, Dr
- Phone Number: 04 72 00 71 65
- Email: vincent.garbit@infirmerie-protestante.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- I1. Male or female patient 18 age or older at time of inform consent signature.
- I2. Patient 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.
- I5. Patient must be covered by a medical insurance.
Exclusion Criteria:
- 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.
- E5. Patient under curatorship, guardianship or judicial protection.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia.
Time Frame: At surgery
|
Rate of immune infiltrate in colorectal tissue
|
At surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transcriptome profiling by RNAseq of neutrophils associated with neoplastic and preneoplastic lesions.
Time Frame: At surgery
|
mRNA level by RNAseq from neutrophils at different preneoplastic and neoplastic stages.
|
At surgery
|
Characterization of lymphocyte cells infiltrate in colorectal tissue (normal, neoplastic and preneoplastic).
Time Frame: At surgery
|
Rate of lymphocyte cells in colorectal tissue (normal, neoplastic and preneoplastic).
|
At surgery
|
Evaluation of the correlation between immune infiltrate and clinical data, microsatellite status and clinical evolution.
Time Frame: At surgery and through study completion, at least 42 months
|
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).
|
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.
Time Frame: At surgery and through study completion, at least 42 months
|
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)
|
At surgery and through study completion, at least 42 months
|
Identification of microbiota modifications in stools and mucosa during colic carcinogenesis
Time Frame: At surgery, at Month 6 post-surgery, at Month 9 post-surgery
|
Sequences of the variable portions of the 16s ribosomal RNA gene
|
At surgery, at Month 6 post-surgery, at Month 9 post-surgery
|
Identification of potential molecular abnormalities in cancer cells from colorectal tissue and from blood samples.
Time Frame: At surgery
|
Circulating tumor DNA and tumor DNA.
|
At surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthieu SARABI, Dr, Centre Leon Berard
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ET18-276 (COLON-IM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States