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The National Myelodysplastic ...

The National Myelodysplastic Syndromes (MDS) Study

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-13

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Multi-center, prospective cohort study enrolling patients from centers in the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP). The accrual period is 5+ years. After central pathology review of registered participants, approximately 2,000 cases of MDS or MDS/MPN overlap disorders, and 500 cases of ICUS will be identified for the longitudinal study cohort and up to 1000 cases will be identified for the cross-sectional cohort. No more than 3500 total participants will be registered. Participants in the longitudinal cohort may be followed for life.

The goal of the National MDS Study is to establish a publicly available resource to facilitate the study of MDS natural history. This will be accomplished through: 1) Creation of a multi-institutional, longitudinal collection of consistently processed and clinically well-annotated blood and tissue specimens collected prospectively from participants with MDS and participants with idiopathic cytopenia of undetermined significance (ICUS); and 2) Support for investigator-initiated studies of MDS that will have high-impact for MDS patients, including basic science, clinical, health outcomes and epidemiological research.

Conditions

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Myelodysplastic Syndromes (MDS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Longitudinal

Participants with MDS, MDS/MPN overlap disorder, AML \<30% blasts without core binding factor or acute promyelocytic leukemia, ICUS, or at risk based on select karyotypic or genetic abnormalities

Therapeutic

Intervention Type OTHER

Observational Study

Cross-sectional

Participants who do not have MDS, MDS/MPN overlap disorder, or ICUS and have the baseline visit only

Therapeutic

Intervention Type OTHER

Observational Study

Interventions

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Therapeutic

Observational Study

Intervention Type OTHER

Eligibility Criteria

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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 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.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikkael Sekeres, MD, MS

Role: STUDY_CHAIR

University of Miami

Amy DeZern, MD, MHS

Role: STUDY_CHAIR

Johns Hopkins University

Locations

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Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Site Status

Kaiser Permanente-Bellflower

Bellflower, California, United States

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Kaiser Permanente-Fontana

Fontana, California, United States

Site Status

Kaiser Permanente - South Bay

Harbor City, California, United States

Site Status

Kaiser Permanente-Irvine

Irvine, California, United States

Site Status

Tibor Rubin VA Medical Center

Long Beach, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Cadillac

Los Angeles, California, United States

Site Status

Va Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Kaiser Permanente - Panorama City

Panorama City, California, United States

Site Status

Eisenhower Medical Center

Rancho Mirage, California, United States

Site Status

Kaiser Permanente-Riverside

Riverside, California, United States

Site Status

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Site Status

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Site Status

Kaiser Permanente-San Marcos

San Marcos, California, United States

Site Status

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Site Status

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Regional Hematology and Oncology PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

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Moffitt Cancer Center

Tampa, Florida, United States

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Indian River Medical Center

Vero Beach, Florida, United States

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Northside Hospital

Atlanta, Georgia, United States

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Augusta University Medical Center

Augusta, Georgia, United States

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Atlanta VA Medical Center

Decatur, Georgia, United States

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Northside Hospital - Duluth

Duluth, Georgia, United States

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Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

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Northside Hospital - Gwinnett

Lawrenceville, Georgia, United States

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Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Site Status