Profile Fecal Analysis of Neutropenic Enterocolitis

• Conditions: Neutropenic Enterocolitis

• Registration Number: NCT04438278
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-07-08
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-22
• Primary Completion: 2022-07-08
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patient>= 18 years old;
• cytological diagnosis of de novo Acute Myeloid Leukemia (AML) (>20% myeloid blasts);
• eligible for intensive chemotherapy (no severe co-morbidity);
• not having received any prior chemotherapy;
• affiliation to the national social security system.

Exclusion Criteria

• acute promyelocytic leukemia (AML 3);
• inability to understand the nature of investigations or to give informed non-opposition;
• person subject to a legal protection measure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shannon index of α-diversity	At day 1, before chemotherapy initiation	Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool

Secondary Outcome Measures

Name	Time	Method
Occurrence of any local neutropenic enterocolitis complications	60 days	Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess
Fecal microbiota's profile	At day 14	Taxonomic identification in shotgun metagenomic
Intensive Care Unit (ICU) - mortality	60 days	Death while hospitalized in the intensive care unit
Biodiversity in microbiota	Day 1, day 14, day 28, day 42	Analysis of alpha and beta-diversity in fecal samples from day 0 to day 60
Hospital - mortality	60 days	Death while hospitalized
1-year mortality	1 year	Death within 1 year of inclusion
Occurrence of malnutrition in patients with severe neutropenic enterocolitis	60 days	Malnutrition defined by the European Society of Clinical nutrition and Metabolism
Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis	60 days	Microbiologically documented infections defined as pneumonia, invasive device infections, urinary tract infections, digestive or neuro-meningitis infections
Whole-blood metatranscriptomic profile evolution	Day 1, day 14, day 28, day 42	Identification of clusters of gene expression

Trial Locations

Locations (1)

AP-HP Hôpital Saint Louis; 🇫🇷 Paris, France