Evaluation of Myelodysplastic Syndromes in Adults and Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to understand the natural history of myelodysplastic syndromes (MDS) and related conditions by collecting clinical data and biological samples from participants. Individuals with suspected or confirmed MDS, as well as healthy donors, will undergo medical history screenings, physical exams, and provide blood and urine samples. Participants will also complete surveys regarding their symptoms and undergo bone marrow biopsies to gather comprehensive information about the disease. The goal is to elucidate the mechanisms driving MDS and identify potential biomarkers for diagnosis and treatment response.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA - MDS Participants
* 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.

INCLUSION CRITERIA - Marrow Control Donor Participants

* Either sex, and must be eligible for marrow donation per NIH Clinical Center requirements.
* No history of hematological malignancies as listed as inclusion in 'Inclusion Criteria - MDS Participants' or current autoimmune disease.
* 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).

INCLUSION CRITERIA - All Participants

* 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 CRITERIA - All Participants

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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Kathy L McGraw, Ph.D. — National Cancer Institute (NCI)
• Study coordinator: Danielle F Pinkiert, R.N.
• Email: danielle.pinkiert@nih.gov
• Phone: (240) 858-7566

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.