Myeloproliferative Neoplasms Clinical Trial

Study of Blood Samples From Newborns With Down Syndrome

Summary

This research study is looking at blood samples from newborns with Down syndrome. Studying the genes expressed in samples of blood from patients with Down syndrome may help doctors identify biomarkers related to cancer.

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Full Description

PRIMARY OBJECTIVES:

I. To further our biological understanding of the natural history of transient myeloproliferative disorder (TMD) and its relationship to subsequent leukemia by facilitating the development of a TMD cell and protein bank, and repository of DNA/RNA from megakaryoblasts for future biological studies.

II. To investigate the biology of TMD molecular changes associated with resolution of TMD or its conversion to acute myeloid leukemia within each mortality-risk group by conducting GATA1 mutational analyses, hematopoiesis clonality studies, assessment of RAS mutations, and genomic instability studies using glycophorin A assays.

III. To determine if high-resolution microarray genomic analysis of TMD blasts (using Affymetrix SNP Genechip technology to assess gene expression, copy number variation, and loss of heterozygosity) can predict the development of subsequent leukemia.

IV. To determine the relationship of minimal residual disease (monitored by peripheral blood flow cytometry and GATA1 mutational studies) to clinical remission status and development of subsequent leukemia within each mortality-risk group of TMD patients.

V. To evaluate the relationship between karyotype (including FISH analysis) and subsequent leukemia in TMD patients.

VI. To examine pharmacogenetics and in vitro drug sensitivity to cytarabine (MTT assay) in blasts from TMD patients.

VII. To examine the relationship of functional polymorphisms in Phase I and Phase II drug detoxification genes, DNA repair, and DNA synthesis pathways that may modify susceptibility to leukemia and outcome in TMD patients.

VIII. To determine the relationship between fibrosis-associated serum factors (e.g., platelet-derived growth factor, transforming growth factor beta, N-terminal peptide of III procollagen, type IV collagen, and hyaluronic acid) and event-free survival.

OUTLINE: This is a multicenter study.

Patients undergo peripheral blood collection periodically for biomarker analysis. Samples are analyzed for GATA1 mutations by real-time PCR, polymorphisms, cytogenetics, and K-RAS mutations, gene expression, drug sensitivity patterns, and minimal residual disease by flow cytometry.

Patients are followed up periodically for 5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of transient myeloproliferative disorder (TMD) at < 90 days of age and meeting 1 of the following criteria:

A diagnosis of Down syndrome or Down syndrome mosaicism AND non-erythroid and non-lymphoid blasts (any amount) in the peripheral blood verified with a second sample

Patients with typical physical characteristics of Down syndrome are allowed before cytogenetic or FISH confirmation of the diagnosis

Trisomy 21-positive leukemic blasts documented by biopsy of any organ (including > 5% non-erythroid/non-lymphoid blasts documented by bone marrow aspirate or biopsy)

Infants with isolated trisomy 21 positivity identified only in the leukemic blasts are allowed
Institutional immunophenotype characterization is required for study enrollment

Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

180

Study ID:

NCT00959283

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 184 Locations for this study

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Children's Hospital of Alabama
Birmingham Alabama, 35233, United States
University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
USA Health Strada Patient Care Center
Mobile Alabama, 36604, United States
Providence Alaska Medical Center
Anchorage Alaska, 99508, United States
Phoenix Childrens Hospital
Phoenix Arizona, 85016, United States
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Kaiser Permanente Downey Medical Center
Downey California, 90242, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Miller Children's and Women's Hospital Long Beach
Long Beach California, 90806, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
Mattel Children's Hospital UCLA
Los Angeles California, 90095, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States
Valley Children's Hospital
Madera California, 93636, United States
Children's Hospital and Research Center at Oakland
Oakland California, 94609, United States
Kaiser Permanente-Oakland
Oakland California, 94611, United States
Children's Hospital of Orange County
Orange California, 92868, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto California, 94304, United States
Sutter Medical Center Sacramento
Sacramento California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Rady Children's Hospital - San Diego
San Diego California, 92123, United States
UCSF Medical Center-Parnassus
San Francisco California, 94143, United States
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States
Children's Hospital Colorado
Aurora Colorado, 80045, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States
Yale University
New Haven Connecticut, 06520, United States
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Lee Memorial Health System
Fort Myers Florida, 33901, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States
AdventHealth Orlando
Orlando Florida, 32803, United States
Arnold Palmer Hospital for Children
Orlando Florida, 32806, United States
Nemours Children's Clinic - Orlando
Orlando Florida, 32806, United States
UF Cancer Center at Orlando Health
Orlando Florida, 32806, United States
Nemours Children's Hospital
Orlando Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola Florida, 32504, United States
Johns Hopkins All Children's Hospital
Saint Petersburg Florida, 33701, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States
Saint Mary's Hospital
West Palm Beach Florida, 33407, United States
Children's Healthcare of Atlanta - Egleston
Atlanta Georgia, 30322, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Saint Luke's Mountain States Tumor Institute
Boise Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago Illinois, 60611, United States
University of Illinois
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn Illinois, 60453, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis Indiana, 46260, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
Norton Children's Hospital
Louisville Kentucky, 40202, United States
Tulane University Health Sciences Center
New Orleans Louisiana, 70112, United States
Children's Hospital New Orleans
New Orleans Louisiana, 70118, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Floating Hospital for Children at Tufts Medical Center
Boston Massachusetts, 02111, United States
Baystate Medical Center
Springfield Massachusetts, 01199, United States
C S Mott Children's Hospital
Ann Arbor Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Michigan State University Clinical Center
East Lansing Michigan, 48824, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Kalamazoo Center for Medical Studies
Kalamazoo Michigan, 49008, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis Minnesota, 55404, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Columbia Regional
Columbia Missouri, 65201, United States
Children's Mercy Hospitals and Clinics
Kansas City Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
Saint Louis Missouri, 63104, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Children's Hospital and Medical Center of Omaha
Omaha Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas Nevada, 89106, United States
Sunrise Hospital and Medical Center
Las Vegas Nevada, 89109, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Saint Joseph's Regional Medical Center
Paterson New Jersey, 07503, United States
Overlook Hospital
Summit New Jersey, 07902, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Albany Medical Center
Albany New York, 12208, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Winthrop Hospital
Mineola New York, 11501, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
Mount Sinai Hospital
New York New York, 10029, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
University of Rochester
Rochester New York, 14642, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
New York Medical College
Valhalla New York, 10595, United States
Mission Hospital Inc-Memorial Campus
Asheville North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
East Carolina University
Greenville North Carolina, 27834, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
Children's Hospital Medical Center of Akron
Akron Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Nationwide Children's Hospital
Columbus Ohio, 43205, United States
Dayton Children's Hospital
Dayton Ohio, 45404, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo Ohio, 43606, United States
Mercy Children's Hospital
Toledo Ohio, 43608, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa Oklahoma, 74136, United States
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States
Legacy Emanuel Hospital and Health Center
Portland Oregon, 97227, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Children's Hospital
Hershey Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15224, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Prisma Health Richland Hospital
Columbia South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
T C Thompson Children's Hospital
Chattanooga Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States
St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo Texas, 79106, United States
Driscoll Children's Hospital
Corpus Christi Texas, 78411, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Cook Children's Medical Center
Fort Worth Texas, 76104, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States
Covenant Children's Hospital
Lubbock Texas, 79410, United States
Children's Hospital of San Antonio
San Antonio Texas, 78207, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Primary Children's Hospital
Salt Lake City Utah, 84113, United States
University of Vermont and State Agricultural College
Burlington Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States
Naval Medical Center - Portsmouth
Portsmouth Virginia, 23708, United States
Carilion Clinic Children's Hospital
Roanoke Virginia, 24014, United States
Seattle Children's Hospital
Seattle Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States
Mary Bridge Children's Hospital and Health Center
Tacoma Washington, 98405, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
West Virginia University Charleston Division
Charleston West Virginia, 25304, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay Wisconsin, 54301, United States
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States
Monash Medical Center-Clayton Campus
Clayton Victoria, 3168, Australia
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth Western Australia, 6008, Australia
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Janeway Child Health Centre
Saint John's Newfoundland and Labrador, A1B 3, Canada
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8N 3, Canada
Kingston Health Sciences Centre
Kingston Ontario, K7L 2, Canada
Children's Hospital
London Ontario, N6A 5, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
The Montreal Children's Hospital of the MUHC
Montreal Quebec, H3H 1, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal Quebec, H3T 1, Canada
Centre Hospitalier Universitaire de Quebec
Quebec , G1V 4, Canada
San Jorge Children's Hospital
San Juan , 00912, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

180

Study ID:

NCT00959283

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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