Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors
| Status: | Recruiting | 
|---|---|
| Conditions: | Cancer, Cancer, Cancer | 
| Therapuetic Areas: | Oncology | 
| Healthy: | No | 
| Age Range: | 18 - 50 | 
| Updated: | 2/24/2019 | 
| Start Date: | October 10, 2017 | 
| End Date: | September 5, 2021 | 
Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma
This research trial studies saliva, semen, and blood samples to determine effects of
chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from
osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes
fertility problems and to learn more about the long term effects.
			chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from
osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes
fertility problems and to learn more about the long term effects.
PRIMARY OBJECTIVES:
I. Determine whether infertility and/or biomarkers of spermatogenesis and steroidogenesis
differ in male osteosarcoma survivors treated with cisplatin with or without ifosfamide
compared to male controls without a history of cancer.
II. Evaluate whether cisplatin with or without ifosfamide for the treatment of osteosarcoma
alters sperm deoxyribonucleic acid (DNA) methylation.
SECONDARY OBJECTIVES:
I. Evaluate the role of genetic susceptibility in the development of impairments in
spermatogenesis or steroidogenesis with contemporary regimens for the treatment of
osteosarcoma.
OUTLINE:
Participants complete a health questionnaire over 30-45 minutes. Patients also provide saliva
and semen samples and undergo collection of blood.
I. Determine whether infertility and/or biomarkers of spermatogenesis and steroidogenesis
differ in male osteosarcoma survivors treated with cisplatin with or without ifosfamide
compared to male controls without a history of cancer.
II. Evaluate whether cisplatin with or without ifosfamide for the treatment of osteosarcoma
alters sperm deoxyribonucleic acid (DNA) methylation.
SECONDARY OBJECTIVES:
I. Evaluate the role of genetic susceptibility in the development of impairments in
spermatogenesis or steroidogenesis with contemporary regimens for the treatment of
osteosarcoma.
OUTLINE:
Participants complete a health questionnaire over 30-45 minutes. Patients also provide saliva
and semen samples and undergo collection of blood.
Inclusion Criteria:
- Living
- Previously enrolled and randomized on AOST0331 or INT0133 (also known as CCG7921 and
POG9351)
- Osteosarcoma survivors without relapse or a subsequent malignancy other than skin
cancer following initial treatment on AOST0331 or INT0133 (also known as CCG7921 and
POG9351)
- Able to speak, read and write in English or Spanish
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
We found this trial at
    66
    sites
	
									1600 7th Avenue
Birmingham, Alabama 35233
	
			Birmingham, Alabama 35233
(205) 638-9100
							 
					Principal Investigator: Smita Bhatia
			
						
								
		Children's Hospital of Alabama Children  
  
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									666 Elm Street
Buffalo, New York 14263
	
			Buffalo, New York 14263
(716) 845-2300 
							 
					Principal Investigator: Denise A. Rokitka
			
						
										Phone: 800-767-9355
					
		Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...  
  
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									3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
	
			Cincinnati, Ohio 45229
 1-513-636-4200  
							 
					Principal Investigator: Rajaram Nagarajan
			
						
								
		Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...  
  
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									700 Childrens Drive
Columbus, Ohio 43205
	
			Columbus, Ohio 43205
(616) 722-2000
							 
					Principal Investigator: Mark A. Ranalli
			
						
								
		Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....  
  
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									3533 South Alameda Street
Corpus Christi, Texas 78411
	
			Corpus Christi, Texas 78411
(361) 694-5000
							 
					Principal Investigator: Nkechi I. Mba
			
						
								
		Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...  
  
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									1200 Pleasant Street
Des Moines, Iowa 50309
	
			Des Moines, Iowa 50309
(515) 241-KIDS
							 
					Principal Investigator: Wendy L. Woods-Swafford
			
						
								
		Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...  
  
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									1500 E Duarte Rd
Duarte, California 91010
	
			Duarte, California 91010
(626) 256-4673
							 
					Principal Investigator: Saro H. Armenian
			
						
										Phone: 800-826-4673
					
		City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...  
  
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									100 Michigan Street Northeast
Grand Rapids, Michigan 49503
	
			Grand Rapids, Michigan 49503
616.391.9000
							 
					Principal Investigator: Kathleen J. Yost
			
						
								
		Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...  
  
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									2500 N State St
Jackson, Mississippi 39216
	
			Jackson, Mississippi 39216
(601) 984-1000 
							 
					Principal Investigator: Anderson (Andy) B. Collier
			
						
										Phone: 601-815-6700
					
		University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...  
  
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									524 South Park Street
Kalamazoo, Michigan 49007
	
			Kalamazoo, Michigan 49007
(269) 341-7654 
							 
					Principal Investigator: Kathleen J. Yost
			
						
										Phone: 616-391-1230
					
		Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...  
  
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									1800 West Charleston Boulevard
Las Vegas, Nevada 89102
	
			Las Vegas, Nevada 89102
(702) 383-2000
							 
					Principal Investigator: Alan K. Ikeda
			
						
										Phone: 702-384-0013
					
		University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...  
  
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									262 Danny Thomas Pl
Memphis, Tennessee 38105
	
			Memphis, Tennessee 38105
(901) 495-3300 
							 
					Principal Investigator: Michael W. Bishop
			
						
								
		St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...  
  
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									 747 52nd St
Oakland, California 94609
	
			Oakland, California 94609
(510) 428-3000
							 
					Principal Investigator: Carla B. Golden
			
						
								
		Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...  
  
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									530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
	
			Peoria, Illinois 61603
(309) 624-4945
							 
					Principal Investigator: Pedro A. De Alarcon
			
						
										Phone: 888-226-4343
					
		Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...  
  
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									South 34th Street
Philadelphia, Pennsylvania 19104
	
			Philadelphia, Pennsylvania 19104
 215-590-1000 
							 
					Principal Investigator: Jill P. Ginsberg
			
						
								
		Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...  
  
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									4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
	
			Pittsburgh, Pennsylvania 15224
412-692-5325 
							 
					Principal Investigator: Jean M. Tersak
			
						
								
		Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...  
  
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									593 Eddy Street
Providence, Rhode Island 02903
	
			Providence, Rhode Island 02903
401-444-4000
							 
					Principal Investigator: Jennifer J. Greene Welch
			
						
										Phone: 401-444-1488
					
		Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...  
  
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									7700 Floyd Curl Dr
San Antonio, Texas 78229
	
			San Antonio, Texas 78229
(210) 575-7000
							 
					Principal Investigator: Vinod K. Gidvani-Diaz
			
						
								
		Methodist Children's Hospital of South Texas Methodist Children  
  
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									4502 Medical Drive
San Antonio, Texas 78284
	
			San Antonio, Texas 78284
(210) 567-7000 
							 
					Principal Investigator: Anne-Marie R. Langevin
			
						
										Phone: 210-450-3800
					
		University of Texas Health Science Center at San Antonio The University of Texas Health Science...  
  
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									3020 Childrens way
San Diego, California 92123
	
			San Diego, California 92123
(858) 576-1700
							 
					Principal Investigator: William D. Roberts
			
						
								
		Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...  
  
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									1600 Rockland Road
Wilmington, Delaware 19803
	
			Wilmington, Delaware 19803
(302) 651-4200
							 
					Principal Investigator: Ramamoorthy Nagasubramanian
			
						
										Phone: 302-651-6884
					
		Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...  
  
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									1540 East Hospital Drive
Ann Arbor, Michigan 48109
	
			Ann Arbor, Michigan 48109
(877) 475-6688
							 
					Principal Investigator: Rajen Mody
			
						
								
		C S Mott Children's Hospital Behind the doors of C.S. Mott Children's Hospital there exist...  
  
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								Atlanta, Georgia 30322			
	
			
					Principal Investigator: Karen E. Effinger
			
						
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									13123 E 16th Ave
Aurora, Colorado 80045
	
			Aurora, Colorado 80045
(720) 777-1234
							 
					Principal Investigator: Timothy P. Garrington
			
						
								
		Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...  
  
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									2401 W Belvedere Ave
Baltimore, Maryland 21215
	
			Baltimore, Maryland 21215
(410) 601-9000
							 
					Principal Investigator: Jason M. Fixler
			
						
										Phone: 410-601-6120
					
		Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...  
  
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									489 State St
Bangor, Maine 04401
	
			Bangor, Maine 04401
(207) 973-7000
							 
					Principal Investigator: Nadine P. SantaCruz
			
						
										Phone: 207-973-4274
					
		Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...  
  
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									55 Fruit St
Boston, Massachusetts 02114
	
			Boston, Massachusetts 02114
(617) 724-4000
							 
					Principal Investigator: A. L. Frazier
			
						
										Phone: 877-726-5130
					
		Massachusetts General Hospital Cancer Center An integral part of one of the world  
  
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									450 Brookline Ave
Boston, Massachusetts 2215
	
			Boston, Massachusetts 2215
617-632-3000 
							 
					Principal Investigator: A. L. Frazier
			
						
										Phone: 877-442-3324
					
		Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...  
  
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								Charlotte, North Carolina 28204			
	
			
					Principal Investigator: Jessica A. Bell
			
						
										Phone: 704-384-5369
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									1200 West Harrison Stree
Chicago, Illinois 60607
	
			Chicago, Illinois 60607
(312) 996-4350
							 
					Principal Investigator: Mary L. Schmidt
			
						
										Phone: 312-355-3046
					
		Univ of Illinois A major research university in the heart of one of the world's...  
  
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								Chicago, Illinois 60614			
	
			
					Principal Investigator: David O. Walterhouse
			
						
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									5841 S Maryland Ave
Chicago, Illinois 60637
	
			Chicago, Illinois 60637
1-773-702-6180
							 
					Principal Investigator: Tara O. Henderson
			
						
										Phone: 773-702-8222
					
		University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...  
  
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									2049 E 100th St
Cleveland, Ohio 44106
	
			Cleveland, Ohio 44106
(216) 444-2200
							 
					Principal Investigator: Rabi Hanna
			
						
										Phone: 866-223-8100
					
		Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...  
  
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								Dallas, Texas 75390			
	
			
					Principal Investigator: Patrick J. Leavey
			
						
										Phone: 214-648-7097
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									4160 John R St #2122
Detroit, Michigan 48201
	
			Detroit, Michigan 48201
(313) 833-1785
							 
					Principal Investigator: Roland L. Chu
			
						
										Phone: 313-576-9790
					
		Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...  
  
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									9333 Imperial Highway
Downey, California 90242
	
			
					Downey, California 90242
Principal Investigator: Robert M. Cooper
			
						
										Phone: 510-891-3400
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									2301 Erwin Rd
Durham, North Carolina 27710
	
			Durham, North Carolina 27710
919-684-8111
							 
					Principal Investigator: Lars M. Wagner
			
						
										Phone: 888-275-3853
					
		Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...  
  
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								Edmonton, Alberta 			
	
			
					Principal Investigator: Sarah J. McKillop
			
						
										Phone: 780-407-6615
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								Fort Myers, Florida 33908			
	
			
					Principal Investigator: Emad K. Salman
			
						
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									801 7th Avenue
Fort Worth, Texas 76104
	
			Fort Worth, Texas 76104
(682) 885-4000
							 
					Principal Investigator: Donald T. Beam
			
						
								
		Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...  
  
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									1600 Southwest Archer Road
Gainesville, Florida 32610
	
			
					Gainesville, Florida 32610
Principal Investigator: William B. Slayton
			
						
										Phone: 352-273-8010
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									900 West Faris Rd.
Greenville, South Carolina 29605
	
			Greenville, South Carolina 29605
(864)455-8898
							 
					Principal Investigator: Nichole L. Bryant
			
						
								
		BI-LO Charities Children's Cancer Center The BI-LO Charities Children  
  
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								Houston, Texas 77030			
	
			
					Principal Investigator: Wendy Allen-Rhoades
			
						
										Phone: 713-798-1354
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									705 Riley Hospital Dr
Indianapolis, Indiana 46202
	
			Indianapolis, Indiana 46202
(317) 944-5000
							 
					Principal Investigator: Kamnesh R. Pradhan
			
						
										Phone: 800-248-1199
					
		Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...  
  
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								Iowa City, Iowa 52242			
	
			
					Principal Investigator: Mariko Sato
			
						
										Phone: 800-237-1225
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								Jacksonville, Florida 32207			
	
			
					Principal Investigator: Ramamoorthy Nagasubramanian
			
						
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								Kansas City, Missouri 64108			
	
			
					Principal Investigator: Keith J. August
			
						
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									2018 W Clinch Ave
Knoxville, Tennessee 37916
	
			Knoxville, Tennessee 37916
(865) 541-8000
							 
					Principal Investigator: Ray C. Pais
			
						
										Phone: 865-541-8266
					
		East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...  
  
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								Las Vegas, Nevada 89109			
	
			
					Principal Investigator: Alan K. Ikeda
			
						
										Phone: 702-384-0013
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								Las Vegas, Nevada 89144			
	
			
					Principal Investigator: Alan K. Ikeda
			
						
										Phone: 702-384-0013
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								Las Vegas, Nevada 89135			
	
			
					Principal Investigator: Alan K. Ikeda
			
						
										Phone: 702-384-0013
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								Lexington, Kentucky 			
	
			
					Principal Investigator: Vlad C. Radulescu
			
						
										Phone: 859-257-3379
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								New Haven, Connecticut 6520			
	
			(203) 432-4771 
							 
					Principal Investigator: Nina S. Kadan-Lottick
			
						
										Phone: 203-785-5702
					
		Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...  
  
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								New Orleans, Louisiana 70121			
	
			
					Principal Investigator: Robert J. Vasquez
			
						
										Phone: 504-703-8712
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									1275 York Ave
New York, New York 10021
	
			New York, New York 10021
(212) 639-2000
							 
					Principal Investigator: Danielle N. Friedman
			
						
										Phone: 212-639-7592
					
		Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...  
  
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									940 NE 13th St
Oklahoma City, Oklahoma 73190
	
			Oklahoma City, Oklahoma 73190
(405) 271-6458 
							 
					Principal Investigator: Rene Y. McNall-Knapp
			
						
										Phone: 405-271-8777
					
		University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...  
  
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									13535 Nemours Parkway
Orlando, Florida 32827
	
			Orlando, Florida 32827
(407) 567-4000
							 
					Principal Investigator: Ramamoorthy Nagasubramanian
			
						
								
		Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...  
  
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								Orlando, Florida 32803			
	
			
					Principal Investigator: Fouad M. Hajjar
			
						
										Phone: 407-303-2090
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									725 Welch Rd
Palo Alto, California 94304
	
			Palo Alto, California 94304
(650) 497-8000
							 
					Principal Investigator: Sheri L. Spunt
			
						
								
		Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...  
  
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									1919 E Thomas Rd
Phoenix, Arizona 85006
	
			Phoenix, Arizona 85006
(602) 933-1000
							 
					Principal Investigator: Jessica Boklan
			
						
										Phone: 602-546-0920
					
		Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...  
  
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								Sacramento, California 95817			
	
			
					Principal Investigator: Marcio H. Malogolowkin
			
						
										Phone: 916-734-3089
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									660 S Euclid Ave
Saint Louis, Missouri 63110
	
			Saint Louis, Missouri 63110
(314) 362-5000 
							 
					Principal Investigator: Robert J. Hayashi
			
						
										Phone: 800-600-3606
					
		Washington University School of Medicine Washington University Physicians is the clinical practice of the School...  
  
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									4800 Sand Point Way NE
Seattle, Washington 98105
	
			Seattle, Washington 98105
(206) 987-2000
							 
					Principal Investigator: Douglas S. Hawkins
			
						
								
		Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...  
  
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									101 W 8th Ave
Spokane, Washington 99204
	
			Spokane, Washington 99204
(509) 474-3131
							 
					Principal Investigator: Judy L. Felgenhauer
			
						
								
		Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...  
  
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								Tampa, Florida 33607			
	
			
					Principal Investigator: Mark J. Mogul
			
						
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