The National Myelodysplastic Syndromes Natural History Study | Aplastic Anemia and MDS International Foundation

ClinicalTrials.gov Identifier:

NCT03030183

Company

NIH MDS Study

Contact Info

Brianna Johnson

bjohnson@emmes.com

Dates

Start: April 2016
End: September 2021

Official Title

The National Myelodysplastic Syndromes Natural History Study

Purpose

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.

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion 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
Exclusion Criteria: 
  • 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)

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