Clinical Trial TitleThe national myelodysplastic syndromes natural history study.
National Clinical Trial Number:NCT02775383
Clinical Trial Protocol Description:
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.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- 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 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
You will be excluded from the study if any of the following criteria apply to you:
- 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)
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.