Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
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|ClinicalTrials.gov Identifier: NCT04460963|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : June 14, 2021
The present study will be divided into 5 phases:
- Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis;
- 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.
- 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)
- 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)
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Other: Adrenomedullin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches|
|Actual Study Start Date :||June 9, 2021|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
Adrenomedullin evaluation at diagnosis at first CR and 1 year of follow-up
Adrenomedullin sample evaluation
- Evaluation of therapeutic potential of ADM inhibition on leukaemia stem cells [ Time Frame: at 1 year ]Rate estimation of the in vitro arrest of leukemic blasts proliferation by ADM inhibition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460963
|Contact: Paola Faziemail@example.com|
|Contact: Enrico Creafirstname.lastname@example.org|
|U.O. Oncoematologia IOV||Recruiting|
|Castelfranco Veneto, Italy|
|Contact: Michele Gottardi|