Evaluating digestive complications in acute myeloid leukemia patients undergoing intensive therapy
Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).
This study is trying to see how often digestive problems happen in patients with acute myeloid leukemia who are getting intensive treatment, especially those with fever and low white blood cell counts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 3 sites (Amiens and 2 other locations) |
| Trial ID | NCT03450512 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of neutropenic enterocolitis and other digestive complications in patients with acute myeloid leukemia (AML) during intensive therapy. It involves a systematic evaluation using CT scans and clinical assessments to identify these complications early, particularly in patients experiencing febrile neutropenia. By monitoring symptoms and conducting imaging at specific intervals, the study seeks to improve diagnostic accuracy and potentially reduce morbidity and mortality associated with these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are receiving intensive treatment for acute myeloid leukemia and are at high risk for neutropenia.
Not a fit: Patients who are minors, those unable to receive intensive therapy for AML, or those with certain comorbidities such as HIV or hepatitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of digestive complications in AML patients, ultimately improving patient outcomes.
How similar studies have performed: This study is novel as there have been no prospective studies specifically evaluating neutropenic enterocolitis and related digestive complications in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * inclusion criteria: Every patient of hematology: * Able to receive an intensive treatment for AML (induction then intensive consolidations) causing a neutropenia with high infectious risk * In state to give its consent * Affiliated to a social security system Exclusion Criteria: * The minor patients * The patients affected by AML not being able to receive an intensive therapy * The patients affected by acute promyelocytic leukaemia * The pregnant women * The patients with HIV, hepatitis B or C * The patients under guardianship or guardianship or deprived of freedom by a court or administrative order (according to articles L1121-6 and L1121-8 of the Public health code)
Where this trial is running
Amiens and 2 other locations
- CHU Amiens-Picardie — Amiens, France (Not_yet_recruiting)
- CHU de Caen — Caen, France (Not_yet_recruiting)
- Henri Becquerel Center — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Delphine LEBON, Doctor
- Email: lebon.delphine@chu-amiens.fr
- Phone: 0033 3 22 45 59 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.