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NHLBI-MDS: Heme: MDS, Registry

The National Myelodysplastic Syndromes Natural History Study

Objective

Overview

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 Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.) MDS or MDS/MPN overlap disorders and undergoing diagnostic workup with planned bone marrow assessments, or diagnosed with de novo or therapy-related MDS within 6-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
  • B12 level, serum folate, ferritin, and Thyroid-Stimulating Hormone (TSH) tests performed in prior 6 months

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.
  • 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)

Phase: N/A

Learn More

ClinicalTrials.Gov

                          IRB Protocol Number
                          NHLBI-MDS
                          Principal Investigator(s)
                          Amanda Hathaway, M.D.

                          Clinical Trial Categories

                          • Hematologic Cancer
                          Sponsor(s)
                          ECOG-ACRIN Cancer Research Group
                          How to Participate

                          Tom Leuck, RN

                          864-560-1980

                          tleuck@gibbscc.org

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