Profile Fecal Analysis of Neutropenic Enterocolitis

NCT ID: NCT04438278

Last Updated: 2021-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-08

Study Completion Date

2023-07-31

Brief Summary

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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

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Conditions

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Neutropenic Enterocolitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AP-HP Hôpital Saint Louis

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lara Zafrani, MD PhD

Role: CONTACT

+33 1 42 49 49 49

References

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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.

Reference Type DERIVED
PMID: 40380332 (View on PubMed)

Other Identifiers

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APHP190826

Identifier Type: -

Identifier Source: org_study_id

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