Post-Ibrutinib Colitis and Intestinal Microbiota

Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03569137

Acronym

COLMI

Enrollment

Registered

2018-06-26

Start date

2018-08-01

Completion date

2020-08-01

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Microbiome

Keywords

Gut Microbiome, hematologic malignancies B, biomarkers, targeted therapy, Gut microbiota

Brief summary

Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* History of uncontrolled colitis before the start of treatment. * Patient with inflammatory bowel disease. * Patient not consenting to participate.

Design outcomes

Primary

Measure	Time frame	Description
difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis	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)

Secondary

Measure	Time frame
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.	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	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	At the end of the study, after 2 years.

Countries

France

Contacts

Primary ContactEmmanuel MONTASSIER, MD

emmanuel.montassier@chu-nantes.fr02 53 48 20 38

Outcome results