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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02775383
Other study ID # NHLBI-MDS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 13, 2016
Est. completion date March 31, 2025

Study information

Verified date April 2024
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact Rayna Ajibolade
Phone 301-251-1161
Email mdsdcc@emmes.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the study of the natural history of MDS.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3500
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Other:
Therapeutic
Observational Study

Locations

Country Name City State
Israel Shaare Zedek Medical Center Jerusalem
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States Avera Cancer Institute-Aberdeen Aberdeen South Dakota
United States Cleveland Clinic Akron General Akron Ohio
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Kaiser Permanente-Anaheim Anaheim California
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Mission Hospital Asheville North Carolina
United States Northside Hospital Atlanta Georgia
United States MultiCare Auburn Medical Center Auburn Washington
United States Augusta University Medical Center Augusta Georgia
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rocky Mountain Regional VA Medical Center Aurora Colorado
United States Dell Seton Medical Center at The University of Texas Austin Texas
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States UM Upper Chesapeake Medical Center Bel Air Maryland
United States Waldo County General Hospital Belfast Maine
United States Kaiser Permanente-Bellflower Bellflower California
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Lehigh Valley Hospital-Muhlenberg Bethlehem Pennsylvania
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare - Bloomington Bloomington Illinois
United States Bozeman Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States IHA Hematology Oncology Consultants-Brighton Brighton Michigan
United States Saint Joseph Mercy Brighton Brighton Michigan
United States James J Peters VA Medical Center Bronx New York
United States Montefiore Medical Center - Einstein Campus Bronx New York
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Ascension Southeast Wisconsin Hospital-Elmbrook Campus Brookfield Wisconsin
United States Maimonides Medical Center Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States IHA Hematology Oncology Consultants-Canton Canton Michigan
United States Saint Joseph Mercy Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States SIH Cancer Institute Carterville Illinois
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Ralph H Johnson VA Medical Center Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Kootenai Medical Center Coeur d'Alene Idaho
United States Mercy Hospital Coon Rapids Minnesota
United States Greater Regional Medical Center Creston Iowa
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Atlanta VA Medical Center Decatur Georgia
United States Cancer Care Specialists of Central Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Northside Hospital - Duluth Duluth Georgia
United States Saint Luke's Hospital of Duluth Duluth Minnesota
United States Durham VA Medical Center Durham North Carolina
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Michigan State University Clinical Center East Lansing Michigan
United States Veterans Administration New Jersey Health Care System East Orange New Jersey
United States Easton Hospital Easton Pennsylvania
United States Marshfield Medical Center - EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States AMITA Health Alexian Brothers Medical Center Elk Grove Village Illinois
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Cleveland Clinic Cancer Center/Fairview Hospital Fairview Ohio
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia
United States Aurora Health Center-Fond du Lac Fontana Wisconsin
United States Kaiser Permanente-Fontana Fontana California
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Ascension Saint Francis-Reiman Cancer Center Franklin Wisconsin
United States Unity Hospital Fridley Minnesota
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Illinois CancerCare - Galesburg Galesburg Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States Adams Cancer Center Gettysburg Pennsylvania
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Glens Falls Hospital Glens Falls New York
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States CHI Health Saint Francis Grand Island Nebraska
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Benefis Healthcare-Sletten Cancer Institute Great Falls Montana
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Prisma Health System Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health System Cancer Institute - Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Self Regional Healthcare Greenwood South Carolina
United States Prisma Health System Cancer Institute - Greer Greer South Carolina
United States Kaiser Permanente - South Bay Harbor City California
United States Geisinger Medical Center - Cancer Center Hazleton Hazleton Pennsylvania
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States AMITA Health Cancer Institute and Outpatient Center Hinsdale Illinois
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States OnCare Hawaii - Liliha Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Cancer Center - POB I Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Cancer Center of Kansas-Independence Independence Kansas
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Kaiser Permanente-Irvine Irvine California
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida
United States Capital Region Southwest Campus Jefferson City Missouri
United States West Michigan Cancer Center Kalamazoo Michigan
United States Presence Saint Mary's Hospital Kankakee Illinois
United States Kansas City Veterans Affairs Medical Center Kansas City Missouri
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin
United States North Shore University Hospital Lake Success New York
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States Memorial Medical Center-Las Cruces Las Cruces New Mexico
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at Mountainview Las Vegas Nevada
United States OptumCare Cancer Care at Oakey Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Northside Hospital - Gwinnett Lawrenceville Georgia
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Sechler Family Cancer Center Lebanon Pennsylvania
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Geisinger Medical Oncology - Lewisburg Lewisburg Pennsylvania
United States Cancer Center of Kansas - Liberal Liberal Kansas
United States Tibor Rubin VA Medical Center Long Beach California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente-Cadillac Los Angeles California
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States William S Middleton VA Medical Center Madison Wisconsin
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Vince Lombardi Cancer Clinic-Marinette Marinette Wisconsin
United States Marshfield Medical Center - Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Minneapolis VA Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Meharry Medical College Nashville Tennessee
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Regional Hematology and Oncology PA Newark Delaware
United States Cancer Center of Kansas - Newton Newton Kansas
United States Stephens Memorial Hospital Norway Maine
United States Cancer Care Specialists of O'Fallon O'Fallon Illinois
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Ascension Mercy Hospital Oshkosh Wisconsin
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Va Palo Alto Health Care System Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare - Peoria Peoria Illinois
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Phoenixville Hospital Phoenixville Pennsylvania
United States Kaiser Permanente Northwest Portland Oregon
United States Oregon Health & Science University Portland Oregon
United States Kootenai Cancer Center Post Falls Idaho
United States Pottstown Hospital Pottstown Pennsylvania
United States Geisinger Cancer Services - Pottsville Pottsville Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Ascension All Saints Hospital Racine Wisconsin
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Eisenhower Medical Center Rancho Mirage California
United States Monument Health Rapid City Hospital Rapid City South Dakota
United States Penn State Health Saint Joseph Medical Center Reading Pennsylvania
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Prisma Health System Cancer Institute - Butternut Reidville South Carolina
United States Marshfield Medical Center - Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Kaiser Permanente-Riverside Riverside California
United States Penobscot Bay Medical Center Rockport Maine
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic - Rolla - Cancer and Hematology Rolla Missouri
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Kaiser Permanente-San Diego Zion San Diego California
United States Veterans Affairs Medical Center - San Francisco San Francisco California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States North Coast Cancer Care Sandusky Ohio
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Seattle Cancer Care Alliance Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Prisma Health System Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Phelps Memorial Hospital Center Sleepy Hollow New York
United States Suburban Hematology Oncology Associates - Snellville Snellville Georgia
United States Maine Medical Partners-South Portland South Portland Maine
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Prisma Health System Cancer Institute - Spartanburg Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Aurora Medical Center in Summit Summit Wisconsin
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States William Beaumont Hospital - Troy Troy Michigan
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States Indian River Medical Center Vero Beach Florida
United States Ascension Medical Group Southeast Wisconsin-Mayfair Road Wauwatosa Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut
United States Marshfield Clinic-Weston Center Weston Wisconsin
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas - Wichita Medical Arts Tower Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States UPMC Susquehanna Williamsport Pennsylvania
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Inspira Medical Center Woodbury Woodbury New Jersey
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Metro Health Hospital Wyoming Michigan
United States WellSpan Health-York Hospital York Pennsylvania
United States York Hospital York Maine
United States IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI) National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients dying Deaths will be reported on study case report forms Through study completion, an average of 3 years
Secondary Number of participants progressing to Acute Myeloid Leukemia (AML) Progression to AML will be reported on study case report forms Through study completion, an average of 3 years
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