Gastrointestinal MicrobiomeCOLMINCT03569137
Post-Ibrutinib Colitis and Intestinal Microbiota
An observational study of Gastrointestinal Microbiome, run by Nantes University Hospital at 1 site in France.
Trial summary
Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Microbiome
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2018to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients hospitalized in the Hematology departments and receiving targeted therapy with Ibrutinib
Who may be able to join
- Age 18 years
- Outside the context of guardianship, -affiliated to the Social Security Regime and
- Having consented to participate in the COLMI study.
- Patient who benefit of treatment by targeted therapy to Ibrutinib
Who cannot join
- History of uncontrolled colitis before the start of treatment.
- Patient with inflammatory bowel disease.
- Patient not consenting to participate.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nantes
Nantes
Emmanuel Montassier, MD, 0253482038, emmanuel.montassier@chu-nantes.fr
Emmanuel Montassier, MD
About this study
Official title: Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.
Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology
- Conditions
- Gastrointestinal Microbiome
- Keywords
- Gut Microbiome, hematologic malignancies B, biomarkers, targeted therapy, Gut microbiota
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis
With the different species and metabolites between the 2 groups of patients (patients developing diarrhea after exposure to Ibrutinib and those not developing diarrhea), we will create a risk score for occurrence of diarrhea during treatment with Ibrutinib, on the previously developed model (Montassier et al, 2016, Genome medicine)
Measured: At the end of the study, after 2 years.
Secondary outcomes (3)
Identify biomarkers of the gut microbiota associated with the occurrence of severe diarrhea (grade 3 and 4 CTCAE, version 4.0) in patients treated with Ibrutinib for malignant hemopathy B.
Measured: At the end of the study, after 2 years.
Identify biomarkers of gut microbiota associated with the occurrence of diarrhea by subgroup: patients treated with Ibrutinib alone, patients treated with Ibrutinib in combination with another molecule
Measured: At the end of the study, after 2 years.
Creation of a predictive score of the occurrence of diarrhea in patients treated with Ibrutinib for malignant hemopathy B, including the biomarkers of the intestinal microbiome and the clinical characteristics of the patient
Measured: At the end of the study, after 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MicrobiomeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Departemental Vendee
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569137
- Sponsor's protocol ID
- RC17_0463
- Acronym
- COLMI
- Status last verified
- Jun 2018
- First submitted
- 14 Jun 2018
- Last updated
- 26 Jun 2018
- 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 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.
- ClinicalTrials.gov ID
- NCT03569137
- Acronym / sponsor ID
- COLMI / RC17_0463
- Conditions
- Gastrointestinal Microbiome
- Keywords
- Gut Microbiome, hematologic malignancies B, biomarkers, targeted therapy, Gut microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier Departemental Vendee
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 26 Jun 2018 (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.
Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology
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
- All patients hospitalized in the Hematology departments and receiving targeted therapy with Ibrutinib
Key inclusion criteria (4 listed)
- Age 18 years
- Outside the context of guardianship, -affiliated to the Social Security Regime and
- Having consented to participate in the COLMI study.
- Patient who benefit of treatment by targeted therapy to Ibrutinib
Key exclusion criteria (3 listed)
- History of uncontrolled colitis before the start of treatment.
- Patient with inflammatory bowel disease.
- Patient not consenting to participate.
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
difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis
Time frame: At the end of the study, after 2 years.
With the different species and metabolites between the 2 groups of patients (patients developing diarrhea after exposure to Ibrutinib and those not developing diarrhea), we will create a risk score for occurrence of diarrhea during treatment with Ibrutinib, on the previously developed model (Montassier et al, 2016, Genome medicine)
3 secondary outcomes
Identify biomarkers of the gut microbiota associated with the occurrence of severe diarrhea (grade 3 and 4 CTCAE, version 4.0) in patients treated with Ibrutinib for malignant hemopathy B.
Time frame: At the end of the study, after 2 years.
Identify biomarkers of gut microbiota associated with the occurrence of diarrhea by subgroup: patients treated with Ibrutinib alone, patients treated with Ibrutinib in combination with another molecule
Time frame: At the end of the study, after 2 years.
Creation of a predictive score of the occurrence of diarrhea in patients treated with Ibrutinib for malignant hemopathy B, including the biomarkers of the intestinal microbiome and the clinical characteristics of the patient
Time frame: At the end of the study, after 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Microbiome, run by Nantes University Hospital at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel MONTASSIER, MD (02 53 48 20 38 ext. +33, emmanuel.montassier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis (time frame: At the end of the study, after 2 years.). 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 26 Jun 2018.