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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
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| Measure | Description | Time Frame |
|---|---|---|
| Shannon index of α-diversity | Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool | At day 1, before chemotherapy initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota's profile | Taxonomic identification in shotgun metagenomic | At day 14 |
| Intensive Care Unit (ICU) - mortality | Death while hospitalized in the intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lara Zafrani, MD PhD | Contact | +33 1 42 49 49 49 | lara.zafrani@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Hôpital Saint Louis | Recruiting | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40380332 | Derived | 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. |
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| ID | Term |
|---|---|
| D044504 | Enterocolitis, Neutropenic |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 60 days |
| Hospital - mortality | Death while hospitalized | 60 days |
| 1-year mortality | Death within 1 year of inclusion | 1 year |
| Occurrence of any local neutropenic enterocolitis complications | Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess | 60 days |
| Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis | Microbiologically documented infections defined as pneumonia, invasive device infections, urinary tract infections, digestive or neuro-meningitis infections | 60 days |
| Occurrence of malnutrition in patients with severe neutropenic enterocolitis | Malnutrition defined by the European Society of Clinical nutrition and Metabolism | 60 days |
| Biodiversity in microbiota | Analysis of alpha and beta-diversity in fecal samples from day 0 to day 60 | Day 1, day 14, day 28, day 42 |
| Whole-blood metatranscriptomic profile evolution | Identification of clusters of gene expression | Day 1, day 14, day 28, day 42 |
| D007410 |
| Intestinal Diseases |