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Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
Plain-language guide to NCT04460963: not phased interventional trial of Adrenomedullin, 72 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04460963
- Phase
- not phased
- Status
- active, not recruiting
- Start
- 2021-06-09
- Completion (planned or actual)
- 2026-06
- Participants
- 72 (estimated)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Acute Myeloid Leukemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Adrenomedullin.
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.
It had 1 arm (groups): Biological evaluation (other).
Adrenomedullin evaluation at diagnosis at first CR and 1 year of follow-up.
The registry classes the interventions as other.
Who Took Part
72 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: patients affected by hiv, b or c hepatitis.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Adrenomedullin study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2021-06-09 with completion listed for 2026-06.
It ran at 5 sites in Italy (5).
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Evaluation of therapeutic potential of ADM inhibition on leukaemia stem cells (time frame: at 1 year).
What This Means in Plain Language
Put simply, this is a not phased trial of Adrenomedullin in 72 people.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Adrenomedullin compound page, all human trials.
Our Notes on the Compound
Adrenomedullin: A 52-amino-acid peptide that widens blood vessels; studied as an infusion in heart, lung and gut conditions.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.