Profile Fecal Analysis of Neutropenic Enterocolitis (PROFANE)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Neutropenic Enterocolitis

Study type: Observational

Funder types: Other

Identifiers

NCT04438278

APHP190826

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.