Neutropenic Enterocolitis
Conditions
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
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit (ICU) - mortality | 60 days | Death while hospitalized in the intensive care unit |
| Hospital - mortality | 60 days | Death while hospitalized |
| 1-year mortality | 1 year | Death within 1 year of inclusion |
| 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 |
| Occurrence of malnutrition in patients with severe neutropenic enterocolitis | 60 days | Malnutrition defined by the European Society of Clinical nutrition and Metabolism |
| 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 |
| Whole-blood metatranscriptomic profile evolution | Day 1, day 14, day 28, day 42 | Identification of clusters of gene expression |
| 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 |
Countries
France
Contacts
Primary ContactLara Zafrani, MD PhD
Outcome results
None listed