Colorectal CancerNCT03841799
COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
An observational study of Colorectal Cancer, run by Centre Leon Berard at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 400 participants
- Where
- 3 sitesFrance
- Study dates
- 2 May 2019to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hopital Saint Joseph Saint Luc
Lyon, Lyon, 69007
MILOU Fabrice, Dr, fmilou@saintjosephsaintluc.fr
- Recruiting
Clinique de L'Infirmerie Protestante
Lyon, 69004
GARBIT Vincent, Dr, 04 72 00 71 65, vincent.garbit@infirmerie-protestante.com
- Recruiting
Centre Leon Berard
Lyon, 69008
Lucas DE CRIGNIS, Dr, 04 78 78 28 28, Lucas.decrignis@lyon.unicancer.fr@lyon.unicancer.fr
About this study
Official title: COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
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).
Read the 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).
- Conditions
- Colorectal Cancer
- Keywords
- Microbiota, Microenvironment colorectal tissue, Immune infiltrate
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia.
Rate of immune infiltrate in colorectal tissue
Measured: At surgery
Secondary outcomes (6)
Transcriptome profiling by RNAseq of neutrophils associated with neoplastic and preneoplastic lesions.
mRNA level by RNAseq from neutrophils at different preneoplastic and neoplastic stages.
Measured: At surgery
Characterization of lymphocyte cells infiltrate in colorectal tissue (normal, neoplastic and preneoplastic).
Rate of lymphocyte cells in colorectal tissue (normal, neoplastic and preneoplastic).
Measured: At surgery
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).
Measured: 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.
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)
Measured: At surgery and through study completion, at least 42 months
Identification of microbiota modifications in stools and mucosa during colic carcinogenesis
Sequences of the variable portions of the 16s ribosomal RNA gene
Measured: 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.
Circulating tumor DNA and tumor DNA.
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start2 May 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu SARABI, Dr, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841799
- Sponsor's protocol ID
- ET18-276 (COLON-IM)
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue
- ClinicalTrials.gov ID
- NCT03841799
- Acronym / sponsor ID
- ET18-276 (COLON-IM)
- Conditions
- Colorectal Cancer
- Keywords
- Microbiota, Microenvironment colorectal tissue, Immune infiltrate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia.
Time frame: At surgery
Rate of immune infiltrate in colorectal tissue
6 secondary outcomes
Transcriptome profiling by RNAseq of neutrophils associated with neoplastic and preneoplastic lesions.
Time frame: At surgery
Characterization of lymphocyte cells infiltrate in colorectal tissue (normal, neoplastic and preneoplastic).
Time frame: 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
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
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
Identification of potential molecular abnormalities in cancer cells from colorectal tissue and from blood samples.
Time frame: At surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthieu SARABI, Dr principal investigator
Centre Leon Berard
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Centre Leon Berard at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwenaelle GARIN (04 26 55 68 24, gwenaelle.garin@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of colorectal tissue microenvironment of patients with locally colorectal neoplasia. (time frame: At surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.