The National Myelodysplastic Syndromes (MDS) Study

Completed

Conditions studied: Myelodysplastic Syndromes (MDS)

In brief

Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed long term. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the study of the natural history of MDS.

Key facts

Study ID

NCT02775383

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

2115

Starts

2016-06-13

Expected to finish

2025-12-31

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.) MDS or MDS/MPN overlap disorders and undergoing diagnostic work-up with planned bone marrow assessments, or diagnosed with de novo or therapy-related MDS within 12 months of enrollment per the World Health Organization (WHO) criteria1 and undergoing clinical evaluation and planned bone marrow assessments to confirm MDS or to evaluate disease status
• Bone marrow aspirate expected to be performed within 1 week of registration, and in all cases must be performed no later than 4 weeks after enrollment
• Age 18 or older
• If anemic without prior MDS diagnosis, B12 level, serum folate, mean corpuscular volume (MCV), red cell distribution width (RDW), ferritin, and iron studies (Iron, total iron-binding capacity (TIBC) test, and percent saturation) must be performed within prior 6 months.

You may not qualify if…

• Prior treatment for MDS at entry and through the time of the entry bone marrow aspirate
• Treatment with hematopoietic growth factors in prior 6 months
• Diagnosis of a solid tumor or hematologic malignancy within two years prior to enrollment except for in situ cancer of the skin (basal or squamous cell), cervix, bladder, breast, or prostate
• Treatment with radiation therapy in the two years prior to registration
• Non-hormonal treatment for malignancy within the two years prior to registration
• Established hereditary bone marrow failure syndrome
• Known primary diagnosis of aplastic anemia, classical paroxysmal nocturnal hemoglobinuria, amegakaryocytic thrombocytopenic purpura, or large granular lymphocyte leukemia
• Enrolled in the Connect® MDS/AML Disease Registry (NCT01688011)

Where it is running

• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Kaiser Permanente - South Bay — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Tibor Rubin VA Medical Center — Long Beach, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Kaiser Permanente-Cadillac — Los Angeles, California, United States
• Va Palo Alto Health Care System — Palo Alto, California, United States
• Kaiser Permanente - Panorama City — Panorama City, California, United States
• Eisenhower Medical Center — Rancho Mirage, California, United States
• Kaiser Permanente-Riverside — Riverside, California, United States
• Kaiser Permanente-San Diego Zion — San Diego, California, United States
• Veterans Affairs Medical Center - San Francisco — San Francisco, California, United States
• Kaiser Permanente-San Marcos — San Marcos, California, United States
• Kaiser Permanente-Woodland Hills — Woodland Hills, California, United States
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States
• Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Veterans Affairs Connecticut Healthcare System-West Haven Campus — West Haven, Connecticut, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Regional Hematology and Oncology PA — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States

Full record on ClinicalTrials.gov

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