Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS

Launched by NATIONAL CANCER INSTITUTE (NCI) · Apr 27, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on understanding myelodysplastic syndromes (MDS), which are conditions where blood cells don't develop properly. There aren't many treatments available for MDS, so researchers are studying how the disease progresses over time and gathering samples to learn more about it. They hope that this research will lead to better treatment options in the future.

Eligible participants include anyone, regardless of age or gender, who has suspected or confirmed MDS or related conditions, as well as healthy individuals who are donating bone marrow for others. Those who join the study will go through a series of assessments, including a physical exam, blood and urine tests, and possibly a bone marrow biopsy, which involves taking a small sample of bone marrow from their body. Participants may also provide additional samples like saliva and stool. After joining, participants will be followed up once a year for up to 20 years, helping researchers gather valuable information about MDS and its effects.

Gender

ALL

Eligibility criteria

• • 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.