Status:
RECRUITING
Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
1-120 years
Brief Summary
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 h...
Detailed Description
Background: * Myelodysplastic syndromes (MDS) are heterogenous stem cell disorders characterized by ineffective hematopoiesis resulting in cellular dysplasia, peripheral cytopenias, and increased ris...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2042
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT05350748
Start Date
August 18 2022
End Date
May 1 2042
Last Update
December 18 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892