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AzTrials

Myelodysplastic Syndromes (MDS)MDSNCT02775383

The National Myelodysplastic Syndromes (MDS) Study

An observational study of Myelodysplastic Syndromes (MDS), run by National Heart, Lung, and Blood Institute (NHLBI) at 281 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes (MDS)
What is being tested?
Therapeutic
How many people
2,115 participants
Where
281 sitesin 2 countries
Study dates
13 Jun 2016to 31 Dec 2025
How long will I take part?
9 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with suspected MDS or MDS/MPN overlap disorder who are undergoing diagnostic workup and bone marrow assessments, and patients diagnosed with MDS within 6-months of enrollment and undergoing clinical evaluation and bone marrow assessments to confirm MDS or evaluate disease status

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

281 sites in 2 countries.

281 sites in 2 countries

United States280 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Northside Hospital

    Atlanta, Georgia, 30342

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • Dell Seton Medical Center at The University of Texas

    Austin, Texas, 78701

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21231

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Waldo County General Hospital

    Belfast, Maine, 04915

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Lehigh Valley Hospital-Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61704

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62901

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17821

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62522

  • Cancer Care Specialists of Central Illinois - Decatur

    Decatur, Illinois, 62568

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50314

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55802

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Michigan State University Clinical Center

    East Lansing, Michigan, 48824

  • Veterans Administration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • Easton Hospital

    Easton, Pennsylvania, 18042

  • Marshfield Medical Center - EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • AMITA Health Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Fairview, Ohio, 44111

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58102

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Aurora Health Center-Fond du Lac

    Fontana, Wisconsin, 54937

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Ascension Saint Francis-Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare-Sletten Cancer Institute

    Great Falls, Montana, 59406

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 53715

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health System Cancer Institute - Eastside

    Greenville, South Carolina, 29605

  • Prisma Health System Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health System Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Kaiser Permanente - South Bay

    Harbor City, California, 90710

  • Geisinger Medical Center - Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • AMITA Health Cancer Institute and Outpatient Center

    Hinsdale, Illinois, 60521

  • Queen's Cancer Center - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96817

  • OnCare Hawaii - Liliha

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 22787

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53412

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • North Shore University Hospital

    Lake Success, New York, 11042

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

  • Memorial Medical Center-Las Cruces

    Las Cruces, New Mexico, 88011

  • OptumCare Cancer Care at Oakey

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • OptumCare Cancer Care at Mountainview

    Las Vegas, Nevada, 89128

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • Kansas Institute of Medicine Cancer and Blood Center

    Lenexa, Kansas, 66219

  • Geisinger Medical Oncology - Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Cancer Center of Kansas - Liberal

    Liberal, Kansas, 67901

  • Tibor Rubin VA Medical Center

    Long Beach, California, 90822

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente-Cadillac

    Los Angeles, California, 90034

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54220

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Vince Lombardi Cancer Clinic-Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center - Marshfield

    Marshfield, Wisconsin, 54449

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06511

  • Yale University

    New Haven, Connecticut, 06520

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Stephens Memorial Hospital

    Norway, Maine, 04268

  • Cancer Care Specialists of O'Fallon

    O'Fallon, Illinois, 62269

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Ascension Mercy Hospital

    Oshkosh, Wisconsin, 54904

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Va Palo Alto Health Care System

    Palo Alto, California, 94304

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Illinois CancerCare - Peoria

    Peoria, Illinois, 61615

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Phoenixville Hospital

    Phoenixville, Pennsylvania, 19460

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Pottstown Hospital

    Pottstown, Pennsylvania, 19464

  • Geisinger Cancer Services - Pottsville

    Pottsville, Pennsylvania, 17901

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Ascension All Saints Hospital

    Racine, Wisconsin, 53405

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota, 57701

  • Penn State Health Saint Joseph Medical Center

    Reading, Pennsylvania, 19605

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Prisma Health System Cancer Institute - Butternut

    Reidville, South Carolina, 29605

  • Marshfield Medical Center - Rice Lake

    Rice Lake, Wisconsin, 54868

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • Penobscot Bay Medical Center

    Rockport, Maine, 04856

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic - Rolla - Cancer and Hematology

    Rolla, Missouri, 65401

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

    Sanford, Maine, 04073

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

    Savannah, Georgia, 31405

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98115

  • Prisma Health System Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55739

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117

  • Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

  • Suburban Hematology Oncology Associates - Snellville

    Snellville, Georgia, 30078

  • Maine Medical Partners-South Portland

    South Portland, Maine, 01406

  • Ascension Providence Hospitals - Southfield

    Southfield, Michigan, 48075

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Prisma Health System Cancer Institute - Spartanburg

    Spartanburg, South Carolina, 29307

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Marshfield Clinic Stevens Point Center

    Stevens Point, Wisconsin, 54482

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center - Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • James J Peters VA Medical Center

    The Bronx, New York, 10468

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48073

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Indian River Medical Center

    Vero Beach, Florida, 32960

  • Ascension Medical Group Southeast Wisconsin-Mayfair Road

    Wauwatosa, Wisconsin, 53226

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Veterans Affairs Connecticut Healthcare System-West Haven Campus

    West Haven, Connecticut, 06516

  • Marshfield Clinic-Weston Center

    Weston, Wisconsin, 54476

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67208

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67218

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • UPMC Susquehanna

    Williamsport, Pennsylvania, 17701

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Inspira Medical Center Woodbury

    Woodbury, New Jersey, 08096

  • Kaiser Permanente-Woodland Hills

    Woodland Hills, California, 91367

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17401

  • York Hospital

    York Village, Maine, 03909

  • IHA Hematology Oncology Consultants-Ann Arbor

    Ypsilanti, Michigan, 48197

Other trials in United States

Israel1 site

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

Other trials in Israel

About this study

Official title: The National Myelodysplastic Syndromes Natural History Study

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.

Read the detailed description

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.

Being tested
Therapeutic
Keywords
National MDS Study, MDS, Idiopathic, cytopenia, cytopenias, ICUS, MDS/MPN, Myeloproliferative Neoplasm, Biorepository
Medical subject headings
Myelodysplastic Syndromes, Cytopenia, Myeloproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TherapeuticOther

    Observational Study

Study groups in NCT02775383
Study groupRoleWhat they receive
LongitudinalParticipants 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
Receives: Other: Therapeutic
Cross-sectionalParticipants who do not have MDS, MDS/MPN overlap disorder, or ICUS and have the baseline visit only
Receives: Other: Therapeutic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients dying

    Deaths will be reported on study case report forms

    Measured: Through study completion, an average of 3 years

Secondary outcomes (1)

  1. Number of participants progressing to Acute Myeloid Leukemia (AML)

    Progression to AML will be reported on study case report forms

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study start13 Jun 2016
  3. Primary completion31 Jul 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,115 participants (actual)
Target duration
9 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775383
Sponsor's protocol ID
NHLBI-MDS
Acronym
MDS
Status last verified
Nov 2025
First submitted
2 May 2016
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Gillis N, Colin-Leitzinger C, Tang YH, Otterstatter M, Sherman S, Zhang L, Moscinski LC, Walker ME, Painter JS, Abel GA, Al Baghdadi T, Deeg HJ, Foran JM, Gore SD, Harrington AM, Kroft SH, Liu JJ, Saber W, Virani S, Bejar R, Lindsley RC, Padron E, Walter MJ, Komrokji R, DeZern AE, Sekeres MA. Clinical, Genetic, and Pathologic Variability in Myelodysplastic Syndromes and Precursor Conditions Across Race, Ethnicity, and Sex. Am J Hematol. 2026 Jun;101(6):1407-1420. doi: 10.1002/ajh.70279. Epub 2026 Mar 29.

    PubMed 41906220

  • DeZern AE, Gillis N, Otterstatter M, Abel G, Padron E, Deeg HJ, Al Baghdadi T, Liu J, Xie Z, Zhang L, Moscinski L, Kroft S, Harrington A, Foran J, Komrokji R, Starczynowski D, Gore S, Saber W, Bejar R, Lindsley RC, Sherman S, Lee C, DiFronzo N, Walter M, Sekeres MA. A novel approach to defining progression in MDS and precursor myeloid conditions in the MDS Natural History Study. Blood Adv. 2026 Apr 28;10(8):2743-2753. doi: 10.1182/bloodadvances.2025018770.

    PubMed 41671442

  • Abel GA, Hebert D, Lee C, Rollison D, Gillis N, Komrokji R, Foran JM, Liu JJ, Al Baghdadi T, Deeg J, Gore S, Saber W, Wilson S, Otterstatter M, Thompson J, Borchert C, Padron E, DeZern A, Cella D, Sekeres MA. Health-related quality of life and vulnerability among people with myelodysplastic syndromes: a US national study. Blood Adv. 2023 Jul 25;7(14):3506-3515. doi: 10.1182/bloodadvances.2022009000.

    PubMed 37146263

  • DeZern AE, Goll JB, Lindsley RC, Bejar R, Wilson SH, Hebert D, Deeg J, Zhang L, Gore S, Al Baghdadi T, Maciejewski J, Liu J, Padron E, Komrojki R, Saber W, Abel G, Kroft SH, Harrington A, Grimes T, Reed H, Fulton RS, DiFronzo NL, Gillis N, Sekeres MA, Walter MJ. Utility of targeted gene sequencing to differentiate myeloid malignancies from other cytopenic conditions. Blood Adv. 2023 Jul 25;7(14):3749-3759. doi: 10.1182/bloodadvances.2022008578.

    PubMed 36947201

Questions about this trial

What is this clinical trial studying?

An observational study of Myelodysplastic Syndromes (MDS), run by National Heart, Lung, and Blood Institute (NHLBI) at 281 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 281 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients dying (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775383, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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