Acute Myeloid Leukemia Clinical Trial
The National Myelodysplastic Syndromes (MDS) Study
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.
Full 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.
Eligibility Criteria
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)
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There are 248 Locations for this study
Anaheim California, 92806, United States More Info
Principal Investigator
Baldwin Park California, 91706, United States More Info
Principal Investigator
Bellflower California, 90706, United States More Info
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Fontana California, 92335, United States More Info
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Harbor City California, 90710, United States More Info
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Irvine California, 92618, United States More Info
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Long Beach California, 90822, United States More Info
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Los Angeles California, 90027, United States More Info
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Los Angeles California, 90034, United States More Info
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Palo Alto California, 94304, United States
Panorama City California, 91402, United States More Info
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Rancho Mirage California, 92270, United States More Info
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Riverside California, 92505, United States More Info
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San Diego California, 92120, United States More Info
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San Francisco California, 94121, United States
San Marcos California, 92078, United States More Info
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Woodland Hills California, 91367, United States More Info
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Aurora Colorado, 80045, United States
New Haven Connecticut, 06511, United States More Info
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New Haven Connecticut, 06520, United States More Info
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West Haven Connecticut, 06516, United States More Info
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Newark Delaware, 19713, United States More Info
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Newark Delaware, 19713, United States More Info
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Newark Delaware, 19713, United States
Newark Delaware, 19718, United States More Info
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Jacksonville Florida, 32207, United States More Info
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Jacksonville Florida, 32224, United States More Info
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Lakeland Florida, 33805, United States More Info
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Tampa Florida, 33612, United States
Vero Beach Florida, 32960, United States
Atlanta Georgia, 30342, United States More Info
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Augusta Georgia, 30912, United States More Info
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Decatur Georgia, 30033, United States More Info
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Duluth Georgia, 30096, United States More Info
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Gainesville Georgia, 30501, United States More Info
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Lawrenceville Georgia, 30046, United States More Info
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Savannah Georgia, 31405, United States More Info
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Snellville Georgia, 30078, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96826, United States More Info
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Coeur d'Alene Idaho, 83814, United States More Info
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Post Falls Idaho, 83854, United States More Info
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Sandpoint Idaho, 83864, United States More Info
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Bloomington Illinois, 61704, United States More Info
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Carbondale Illinois, 62901, United States More Info
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Carterville Illinois, 62918, United States More Info
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Centralia Illinois, 62801, United States More Info
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Danville Illinois, 61832, United States More Info
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Decatur Illinois, 62522, United States More Info
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Decatur Illinois, 62568, United States More Info
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Effingham Illinois, 62401, United States More Info
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Effingham Illinois, 62401, United States More Info
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Elk Grove Village Illinois, 60007, United States More Info
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Galesburg Illinois, 61401, United States More Info
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Hinsdale Illinois, 60521, United States More Info
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Kankakee Illinois, 60901, United States More Info
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Mattoon Illinois, 61938, United States More Info
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O'Fallon Illinois, 62269, United States More Info
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Peoria Illinois, 61615, United States More Info
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Urbana Illinois, 61801, United States More Info
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Cedar Rapids Iowa, 52403, United States More Info
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Cedar Rapids Iowa, 52403, United States More Info
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Clive Iowa, 50325, United States More Info
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Clive Iowa, 50325, United States More Info
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Creston Iowa, 50801, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Des Moines Iowa, 50314, United States More Info
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Des Moines Iowa, 50314, United States More Info
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Des Moines Iowa, 50314, United States More Info
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West Des Moines Iowa, 50266, United States More Info
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Chanute Kansas, 66720, United States More Info
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Dodge City Kansas, 67801, United States More Info
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Fort Scott Kansas, 66701, United States More Info
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Independence Kansas, 67301, United States More Info
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Kingman Kansas, 67068, United States More Info
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Lawrence Kansas, 66044, United States More Info
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Lenexa Kansas, 66219, United States More Info
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Liberal Kansas, 67901, United States More Info
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Newton Kansas, 67114, United States More Info
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Parsons Kansas, 67357, United States More Info
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Pratt Kansas, 67124, United States More Info
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Salina Kansas, 67401, United States More Info
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Wellington Kansas, 67152, United States More Info
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Wichita Kansas, 67208, United States More Info
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Wichita Kansas, 67208, United States More Info
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Wichita Kansas, 67208, United States More Info
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Wichita Kansas, 67218, United States More Info
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Winfield Kansas, 67156, United States More Info
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Augusta Maine, 04330, United States
Belfast Maine, 04915, United States
Biddeford Maine, 04005, United States
Norway Maine, 04268, United States
Rockport Maine, 04856, United States
Sanford Maine, 04073, United States
South Portland Maine, 01406, United States
York Maine, 03909, United States More Info
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Baltimore Maryland, 21231, United States More Info
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Bel Air Maryland, 21014, United States More Info
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Bethesda Maryland, 20889, United States More Info
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Worcester Massachusetts, 01655, United States More Info
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Ann Arbor Michigan, 48106, United States More Info
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Brighton Michigan, 48114, United States More Info
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Brighton Michigan, 48114, United States More Info
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Canton Michigan, 48188, United States More Info
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Canton Michigan, 48188, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Dearborn Michigan, 48124, United States More Info
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East Lansing Michigan, 48824, United States
Grand Rapids Michigan, 49503, United States More Info
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Kalamazoo Michigan, 22787, United States More Info
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Reed City Michigan, 49677, United States More Info
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Royal Oak Michigan, 48073, United States More Info
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Saginaw Michigan, 48601, United States More Info
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Southfield Michigan, 48075, United States
Troy Michigan, 48073, United States More Info
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Wyoming Michigan, 49519, United States More Info
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Ypsilanti Michigan, 48197, United States More Info
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Bemidji Minnesota, 56601, United States More Info
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Coon Rapids Minnesota, 55433, United States More Info
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Duluth Minnesota, 55802, United States More Info
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Duluth Minnesota, 55805, United States More Info
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Duluth Minnesota, 55805, United States More Info
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Duluth Minnesota, 55805, United States More Info
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Edina Minnesota, 55435, United States More Info
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Fridley Minnesota, 55432, United States More Info
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Minneapolis Minnesota, 55407, United States More Info
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Minneapolis Minnesota, 55417, United States More Info
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Saint Louis Park Minnesota, 55416, United States More Info
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Saint Paul Minnesota, 55102, United States More Info
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Shakopee Minnesota, 55739, United States More Info
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Cape Girardeau Missouri, 63703, United States More Info
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Jefferson City Missouri, 65109, United States More Info
Principal Investigator
Kansas City Missouri, 64128, United States More Info
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Rolla Missouri, 65401, United States More Info
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Rolla Missouri, 65401, United States More Info
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Saint Joseph Missouri, 64506, United States More Info
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Springfield Missouri, 65804, United States More Info
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Springfield Missouri, 65807, United States More Info
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Anaconda Montana, 59711, United States More Info
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Bozeman Montana, 59715, United States More Info
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Great Falls Montana, 59406, United States More Info
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Grand Island Nebraska, 68803, United States More Info
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Henderson Nevada, 89052, United States More Info
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Las Vegas Nevada, 89102, United States More Info
Las Vegas Nevada, 89103, United States More Info
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Las Vegas Nevada, 89128, United States More Info
Principal Investigator
Las Vegas Nevada, 89135, United States More Info
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Las Vegas Nevada, 89148, United States More Info
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East Orange New Jersey, 07018, United States More Info
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Woodbury New Jersey, 08096, United States More Info
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Albuquerque New Mexico, 87106, United States More Info
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Las Cruces New Mexico, 88011, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States More Info
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Bronx New York, 10468, United States More Info
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Brooklyn New York, 11219, United States
Buffalo New York, 14263, United States More Info
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Elmira New York, 14905, United States More Info
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Glens Falls New York, 12801, United States
Lake Success New York, 11042, United States More Info
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Lake Success New York, 11042, United States More Info
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New Hyde Park New York, 11040, United States More Info
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Sleepy Hollow New York, 10591, United States
Asheville North Carolina, 28801, United States More Info
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Durham North Carolina, 27705, United States
Bismarck North Dakota, 58501, United States More Info
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Fargo North Dakota, 58102, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Akron Ohio, 44307, United States More Info
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Cleveland Ohio, 44109, United States More Info
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Cleveland Ohio, 44195, United States More Info
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Fairview Ohio, 44111, United States More Info
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Independence Ohio, 44131, United States More Info
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Mansfield Ohio, 44906, United States More Info
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Mayfield Heights Ohio, 44124, United States More Info
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Sandusky Ohio, 44870, United States More Info
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Wooster Ohio, 44691, United States More Info
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Lawton Oklahoma, 73505, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Oklahoma City Oklahoma, 73120, United States More Info
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Portland Oregon, 97227, United States More Info
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Portland Oregon, 97239, United States More Info
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Allentown Pennsylvania, 18103, United States More Info
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Bethlehem Pennsylvania, 18017, United States More Info
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Danville Pennsylvania, 17821, United States More Info
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Easton Pennsylvania, 18042, United States More Info
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Ephrata Pennsylvania, 17522, United States More Info
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Gettysburg Pennsylvania, 17325, United States More Info
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Hazleton Pennsylvania, 18201, United States More Info
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Lebanon Pennsylvania, 17042, United States More Info
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Lewisburg Pennsylvania, 17837, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Phoenixville Pennsylvania, 19460, United States More Info
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Pottstown Pennsylvania, 19464, United States More Info
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Pottsville Pennsylvania, 17901, United States More Info
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Reading Pennsylvania, 19605, United States More Info
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Wilkes-Barre Pennsylvania, 18711, United States More Info
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Williamsport Pennsylvania, 17701, United States More Info
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York Pennsylvania, 17401, United States More Info
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Charleston South Carolina, 29401, United States More Info
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Easley South Carolina, 29640, United States More Info
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Greenville South Carolina, 29601, United States More Info
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Greenville South Carolina, 29605, United States More Info
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Greenville South Carolina, 29605, United States More Info
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Greenville South Carolina, 29607, United States More Info
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Greenwood South Carolina, 29646, United States More Info
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Greer South Carolina, 29650, United States More Info
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Reidville South Carolina, 29605, United States More Info
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Seneca South Carolina, 29672, United States More Info
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Spartanburg South Carolina, 29303, United States More Info
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Spartanburg South Carolina, 29307, United States More Info
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Aberdeen South Dakota, 57401, United States More Info
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Rapid City South Dakota, 57701, United States More Info
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Sioux Falls South Dakota, 57104, United States More Info
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Sioux Falls South Dakota, 57105, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Memphis Tennessee, 38120, United States More Info
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Nashville Tennessee, 37208, United States More Info
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Austin Texas, 78701, United States More Info
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Dallas Texas, 75390, United States More Info
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Richardson Texas, 75080, United States More Info
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San Antonio Texas, 78229, United States More Info
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Fishersville Virginia, 22939, United States More Info
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Auburn Washington, 98001, United States More Info
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Bremerton Washington, 98310, United States More Info
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Bremerton Washington, 98310, United States More Info
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Gig Harbor Washington, 98335, United States More Info
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Poulsbo Washington, 98370, United States More Info
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Puyallup Washington, 98372, United States More Info
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Seattle Washington, 98109, United States More Info
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Seattle Washington, 98109, United States More Info
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Seattle Washington, 98115, United States More Info
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Tacoma Washington, 98405, United States More Info
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Charleston West Virginia, 25304, United States More Info
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Brookfield Wisconsin, 53045, United States
Burlington Wisconsin, 53105, United States More Info
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Eau Claire Wisconsin, 54701, United States More Info
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Fontana Wisconsin, 54937, United States More Info
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Franklin Wisconsin, 53132, United States
Germantown Wisconsin, 53022, United States More Info
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Grafton Wisconsin, 53024, United States More Info
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Green Bay Wisconsin, 53715, United States More Info
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Green Bay Wisconsin, 54301, United States More Info
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Green Bay Wisconsin, 54311, United States More Info
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Kenosha Wisconsin, 53412, United States More Info
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La Crosse Wisconsin, 54601, United States More Info
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La Crosse Wisconsin, 54601, United States More Info
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Madison Wisconsin, 53705, United States More Info
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Madison Wisconsin, 53792, United States More Info
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Manitowoc Wisconsin, 54220, United States More Info
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Marinette Wisconsin, 54143, United States More Info
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Marinette Wisconsin, 54143, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Milwaukee Wisconsin, 53215, United States More Info
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Milwaukee Wisconsin, 53226, United States More Info
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Milwaukee Wisconsin, 53233, United States More Info
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Minocqua Wisconsin, 54548, United States More Info
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Oshkosh Wisconsin, 54904, United States
Oshkosh Wisconsin, 54904, United States More Info
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Racine Wisconsin, 53405, United States
Racine Wisconsin, 53406, United States More Info
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Rice Lake Wisconsin, 54868, United States More Info
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Sheboygan Wisconsin, 53081, United States More Info
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Stevens Point Wisconsin, 54482, United States More Info
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Summit Wisconsin, 53066, United States More Info
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Two Rivers Wisconsin, 54241, United States More Info
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Wauwatosa Wisconsin, 53226, United States
Wauwatosa Wisconsin, 53226, United States More Info
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West Allis Wisconsin, 53227, United States More Info
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Weston Wisconsin, 54476, United States More Info
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Jerusalem , 91031, Israel More Info
Principal Investigator
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