Post-Ibrutinib Colitis and Intestinal Microbiota

Gastrointestinal Microbiome Clinical Trial

— COLMI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03569137
• Other study ID #: RC17_0463
• Status: Not yet recruiting
• Start date: August 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: June 2018
• Source: Nantes University Hospital
• Contact: Emmanuel MONTASSIER, MD
• Phone: 02 53 48 20 38
• Email: emmanuel.montassier[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Microbiome

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Vendee Departmental hospital center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At the end of the study, after 2 years.
Secondary	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.
Secondary	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.
Secondary	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.