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Observational Study of Myelodysplastic Syndromes (MDS)

This is an observational study for people with Myelodysplastic Syndromes (MDS), a condition where the cells that make blood are abnormal. Researchers want to understand the natural course of MDS and similar conditions like MDS/myeloproliferative neoplasms (MDS/MPN) to help develop better treatments. They will collect biological samples to learn more about the disease. The main goal is to understand how MDS progresses and to measure how long people live overall and without their disease getting worse, over a 5-year period. You can join if you have suspected or confirmed MDS or related conditions. Healthy donors are also needed, such as those donating bone marrow for a relative or in another study.

Study design
This is an observational study with a planned enrollment of 1100 participants, including those with MDS and healthy donors. It is not specified if it is randomized or blinded.
What's involved
You will have a medical history taken and a physical exam. The trial record does not specify other procedures or the duration of participation.
Compensation
Not stated in the trial record.
Follow-up
The study aims to assess overall and progression-free survival, measured at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05350748

Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS

Recruiting
Not specifiedAges 1+Observational
National Cancer Institute (NCI)
~1,100 participants
Updated 2026-07-23 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
characterize the natural history of myelodysplastic syndromes (MDS) and to assess overall and progression free survival
Measured over 5 years

Conditions

Myelodysplastic Syndromes

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Acute Myeloid LeukemiaAtypical Chronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaClonal Cytopenia of Unknown SignificanceClonal Hematopoiesis of Indeterminate PotentialMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Kathy L McGraw, Ph.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Danielle F Pinkiert, R.N.
[email protected]
(240) 858-7566
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Either sex, any age.
Histologically or cytologically suspected or confirmed myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN), MDS/myeloproliferative neoplasm with ringed sideroblasts and thrombocytosis (MDS/MPN-RS-T), myelodysplastic syndromes/myeloproliferative neoplasms unclassified (MDS/MPN-U), chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), secondary acute myeloid leukemia (sAML) with antecedent MDS or MDS/MPN, or participants who have precursor conditions that are associated with a risk of progression to MDS, including but not limited to clonal hematopoiesis of indeterminate potential (CHIP) and clonal cytopenia of unknown significance (CCUS).
Participants may have had any amount of prior therapy and may be receiving MDS-directed therapy at time of enrollment.
Participants must have an identified primary oncologist, hematologist or generalist outside of NIH who agrees to manage participant care and any diagnostic findings provided by this study.
Either sex, and must be eligible for marrow donation per NIH Clinical Center requirements.
Must be scheduled for bone marrow harvest for clinical application (e.g., marrow donation); or, if being evaluated for malignancy, have a clinical bone marrow aspirate scheduled (e.g., to rule out bone marrow involvement).
Stated willingness to comply with all study procedures and availability for the duration of the study.
Ability of participant or parent/guardian to understand and the willingness to sign a written consent document.

Exclusion

Uncontrolled intercurrent illness, psychiatric illness, or other that would limit compliance with study requirements, or at the investigator s discretion.

What this trial measures

  • characterize the natural history of myelodysplastic syndromes (MDS) and to assess overall and progression free survival5 years

    report the overall survival and progression status of participants