NCT04460963Active, not recruiting
Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
The present study will be divided into 5 phases: 1. Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis; 2. Measurement of Midregional Proadrenomedullin (MR-proADM) plasma concentrations with an Immunoluminometric Assay of newly diagnosed AML patients not affected by concomitant cardiovascular disease or sepsis. 3. Analysis of exosomes and microvesicles derived from PB and bone marrow samples of AML patients and culture media collected from AML samples stimulated with ADM and/or ADM (22-52) 4. Study of adrenomedullin system in leukemic stem cells (CD44+/CD38-/CD31+/Lin-) in order to define a correlated expression of ADM and ADM receptors (RAMPs, PAM) with adhesion molecules (CD31, CD38, CD44s, CD44v6), cell cycle regulatory proteins (p21, p27) and genes or molecules involved in the hematopoietic differentiation process (Cul5, CD11b, CD11c, CD66, CD14, CD15, PML-RARα) 5. In vitro evaluation of ADM activity in the growth, maturation and trans-endothelial migration of blasts and/or fusion of leukemic cells with endothelial cells. To do this, leukemic cells will be alternatively cultured by using in vitro models of endosteal and vascular niches.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 25 Jun 2020
- Start date
- 9 Jun 2021
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04460963
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 9 Jun 2021 to the primary completion date, 30 Jun 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients affected by HIV, B or C hepatitis.
Lab values
- Patients affected by concomitant cardiovascular disease , such as essential hypertension (any grade), chronic renal failure (creatinine\>1.5 mg/dL), heart failure (any NYHA class), and peripheral arterial occlusive diseases, or sepsis.
Who the study is looking for
- Patients with new diagnosis of primary or secondary AML.
- Participant is willing and able to give signed written informed consent according to ICH/EU/GCP and national local laws.
- Male or Female, aged \>18 years.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico S. Orsola-Malpighi - Uoc Ematologia Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| U.O. Oncoematologia IOV Coordinator of this site? Confirm its status | Castelfranco Veneto | Italy | Unknown status |
| Ente Ecclesiastico Casa Sollievo Della Sofferenza - Ematologia Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| Uo Ematologia - Azienda Ulss N.2 Marca Trevigiana Coordinator of this site? Confirm its status | Treviso | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.