Completed

MDSPublic Resource for MDS Natural History Study: A Collection of Well-Annotated Blood and Tissue Specimens

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Study Aim

This observational study aims to collect and analyze well-annotated blood and tissue specimens from patients with Myelodysplastic Syndromes (MDS), with the primary outcome being the number of patients passing away during the study period.

What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Cytopenia+3

+ Bone Marrow Diseases

+ Hematologic Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2016
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 13, 2016

Actual date on which the first participant was enrolled.

The National Myelodysplastic Syndromes (MDS) Natural History Study is a large, multi-center research project focusing on individuals diagnosed with MDS or MDS/MPN overlap disorders, and a condition called idiopathic cytopenia of undetermined significance (ICUS). Over a period of 5+ years, up to 3500 participants will be registered, with approximately 2,000 MDS or MDS/MPN cases and 500 ICUS cases forming a longitudinal study cohort, while up to 1000 cases will be part of a cross-sectional cohort. The aim of this study is to create a valuable, publicly accessible resource to better understand the natural progression of MDS. This resource could significantly improve care and address unmet needs for those affected by this condition. Participants in the longitudinal cohort may be followed for life. The study involves collecting and processing blood and tissue samples consistently across all institutions, ensuring detailed clinical annotations. The primary outcome of the study is to record the number of patients who pass away, which will be reported through study case report forms. The study also aims to support investigator-initiated research on MDS, including basic science, clinical, health outcomes and epidemiological studies, which could have a high impact on MDS patients.

Official TitleThe National Myelodysplastic Syndromes Natural History Study
NCT02775383
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2115 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesMyeloproliferative Disorders

Criteria

4 inclusion criteria required to participate
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.
8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 281 locations

Suspended

Kaiser Permanente-Irvine

Irvine, United StatesOpen Kaiser Permanente-Irvine in Google Maps
Suspended

Medical Oncology and Hematology Associates-Laurel

Des Moines, United States
Suspended

Mercy Medical Center - Des Moines

Des Moines, United States
Suspended

Mercy Medical Center-West Lakes

West Des Moines, United States
Completed281 Study Centers