Profile Fecal Analysis of Neutropenic Enterocolitis
PROFANE
Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJune 22, 2021
June 1, 2021
2 years
May 26, 2020
June 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Shannon index of α-diversity
Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool
At day 1, before chemotherapy initiation
Secondary Outcomes (9)
Fecal microbiota's profile
At day 14
Intensive Care Unit (ICU) - mortality
60 days
Hospital - mortality
60 days
1-year mortality
1 year
Occurrence of any local neutropenic enterocolitis complications
60 days
- +4 more secondary outcomes
Eligibility Criteria
Adult patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML)
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AP-HP Hôpital Saint Louis
Paris, France
Related Publications (1)
Kapandji N, Salmona M, Lemoine A, Ulmann G, Calderaro J, Roche B, Kapel N, Biard L, Lengline E, Goff JL, Rodriguez C, Thomas M, Zafrani L. Unravelling neutropenic enterocolitis: insights from gut microbiota, and intestinal barrier analyses. Exp Hematol Oncol. 2025 May 16;14(1):74. doi: 10.1186/s40164-025-00661-4.
PMID: 40380332DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2020
First Posted
June 18, 2020
Study Start
July 8, 2020
Primary Completion
July 8, 2022
Study Completion
July 1, 2023
Last Updated
June 22, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share