Actively Recruiting
Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS
Led by National Cancer Institute (NCI) · Updated on 2026-05-08
1100
Participants Needed
1
Research Sites
1028 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Myelodysplastic syndromes (MDS) occur when the cells that make blood cells are abnormal. There are limited treatment options for MDS. Researchers want to learn more through this natural history study so they can develop better treatments. Objective: To study the natural course of MDS and MDS/myeloproliferative neoplasms (MPN) and collect biological samples that can help researchers understand the disease. Eligibility: People with suspected or confirmed MDS or MDS/MPN. Healthy donors are also needed. They can be people who are scheduled to donate bone marrow at NIH for a relative, or they may be providing bone marrow in another study. Design: Participants will be screened with a medical history. Participants will have a physical exam. They will give blood and urine samples. They will discuss their symptoms, medications, and ability to perform their normal activities. They will complete surveys about how they are feeling. Participants will have a bone marrow biopsy. A needle will be inserted through a small cut. Bone marrow will be removed. A small piece of bone may be removed. Participants may have an optional skin biopsy. Participants may give optional saliva and stool samples. They may collect these samples at home and mail them to NIH. Participants may undergo optional apheresis. One or two needles or intravenous (IV) lines will be placed in their arm, neck, or groin veins. Blood will be removed. A machine will separate out the white cells. The rest of the blood will be returned to the participant. Participants will be contacted for follow-up once a year for up to 20 years. Healthy donors will have marrow collected for this study during their scheduled procedure with no follow-up.
CONDITIONS
Official Title
Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of any age and either sex with suspected or confirmed myelodysplastic syndromes (MDS) or related conditions including MDS/MPN, MDS/MPN-RS-T, MDS/MPN-U, CMML, aCML, sAML with antecedent MDS or MDS/MPN, or precursor conditions like CHIP or CCUS
- Participants may have had any prior therapy and may currently be receiving MDS-directed treatment
- Participants must have a primary oncologist, hematologist, or generalist outside NIH who agrees to manage their care and diagnostic findings
- Healthy marrow donor participants of either sex who meet NIH Clinical Center eligibility for marrow donation
- Donors must have no history of hematological malignancies listed for MDS participants or current autoimmune diseases
- Donors must be scheduled for bone marrow harvest for clinical use or have a scheduled bone marrow aspirate to rule out malignancy
- Willingness to comply with all study procedures and availability for the study duration
- Ability of participant or parent/guardian to understand and sign written consent
You will not qualify if you...
- Uncontrolled intercurrent illness, psychiatric illness, or other conditions that would limit compliance with study requirements or as determined by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Ashley E Carpenter
CONTACT
K
Kathy L McGraw, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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