DNA Variations in the Gene in Young Patients With Wilms' Tumor

NCT ID: NCT00088803

Last Updated: 2016-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Brief Summary

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RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young patients with Wilms' tumor.

Detailed Description

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OBJECTIVES:

Primary

* Determine the presence of the A133S polymorphism in the RASSF1A tumor suppressor gene by screening germline DNAs of children with Wilms' tumor.
* Determine the inheritance pattern of the A133S polymorphism by evaluating the parents of children who carry this polymorphism.

Secondary

* Determine the differences in age at diagnosis, stage, histology, site of primary tumor, and outcome, between patients with vs without the A133S polymorphism.
* Determine whether the S131F RASSF1A variant is a true polymorphism in these patients.
* Determine the polymorphic differences in this gene between these patients based on ethnicity and sex.

OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis, stage, histology, site of primary tumor, and outcome.

Genomic DNA samples are purified from peripheral blood of patients and controls and analyzed by polymerase chain reaction for the RASSF1A gene. DNA is also analyzed from parents of patients with the A133S polymorphism.

PROJECTED ACCRUAL: A total of 471 participants (229 Wilms' tumor patients and 200 control participants plus 42 parents) will be accrued for this study.

Conditions

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Kidney Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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molecular genetic technique

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of Wilms' tumor OR
* Control participants matched for race, sex, and age

* No prior or concurrent history of cancer OR
* Parents of children involved in the study

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail E. Tomlinson, MD, PhD

Role: STUDY_CHAIR

Simmons Cancer Center

Locations

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University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

University of South Alabama Cancer Research Institute

Mobile, Alabama, United States

Site Status

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Southern California Permanente Medical Group

Downey, California, United States

Site Status

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

Children's Hospital Central California

Madera, California, United States

Site Status

Children's Hospital and Research Center at Oakland

Oakland, California, United States

Site Status

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, United States

Site Status

Children's Hospital and Health Center, San Diego

San Diego, California, United States

Site Status

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

David Grant Medical Center

Travis Air Force Base, California, United States

Site Status

Children's Hospital of Denver

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Site Status

Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Broward General Medical Center

Fort Lauderdale, Florida, United States

Site Status

Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status

Shands Cancer Center at the University of Florida Health Science Center

Gainesville, Florida, United States

Site Status

Joe DiMaggio Children's Hospital at Memorial

Hollywood, Florida, United States

Site Status

Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Miami Children's Hospital

Miami, Florida, United States

Site Status

Baptist-South Miami Regional Cancer Program

Miami, Florida, United States

Site Status

Florida Hospital Cancer Institute

Orlando, Florida, United States

Site Status

Nemours Children's Clinic-Orlando

Orlando, Florida, United States

Site Status

Sacred Heart Children's Hospital

Pensacola, Florida, United States

Site Status

All Children's Hospital

St. Petersburg, Florida, United States

Site Status

St. Joseph's Children's Hospital

Tampa, Florida, United States

Site Status

St. Mary's Hospital

West Palm Beach, Florida, United States

Site Status

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Medical Center of Central Georgia

Macon, Georgia, United States

Site Status

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Site Status

MBCCOP - Hawaii

Honolulu, Hawaii, United States

Site Status

Mountain States Tumor Institute - Boise

Boise, Idaho, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois Medical Center

Chicago, Illinois, United States

Site Status

Children's Memorial Hospital - Chicago

Chicago, Illinois, United States

Site Status

Advocate Hope Children's Hospital

Oak Lawn, Illinois, United States

Site Status

Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Site Status

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Riley Children Cancer Center at Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

St. Vincent Hospitals and Health Care Centers

Indianapolis, Indiana, United States

Site Status

Blank Children's Hospital

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

Site Status

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Site Status

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, United States

Site Status

Children's Hospital of New Orleans

New Orleans, Louisiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Maine Children's Cancer Program

Scarborough, Maine, United States

Site Status

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Walter Reed Army Medical Center

Silver Spring, Maryland, United States

Site Status

Floating Hospital for Children

Boston, Massachusetts, United States

Site Status

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Baystate Regional Cancer Program at Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, United States

Site Status

Van Elslander Cancer Center at St. John Hospital and Medical Center

Detroit, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Spectrum Health and DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, United States

Site Status

CCOP - Beaumont

Royal Oak, Michigan, United States

Site Status

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Site Status

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, United States

Site Status

Children's Hospitals and Clinics - Minneapolis

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

Children's Hospitals and Clinics - Minnesota

Saint Paul, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Children's Hospital of Omaha

Omaha, Nebraska, United States

Site Status

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Cancer Institute of New Jersey at Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, United States

Site Status

Valerie Fund Children's Center at Atlantic Health

Summit, New Jersey, United States

Site Status

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

Site Status

Cancer Center of Albany Medical Center

Albany, New York, United States

Site Status

Brooklyn Hospital Center

Brooklyn, New York, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Brookdale University Hospital and Medical Center

Brooklyn, New York, United States

Site Status

Comprehensive Cancer Center at Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Schneider Children's Hospital

New Hyde Park, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Site Status

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Site Status

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, United States

Site Status

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Site Status

Albert Einstein Clinical Cancer Center

The Bronx, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Mission Hospitals

Asheville, North Carolina, United States

Site Status

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Presbyterian Healthcare

Charlotte, North Carolina, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

Greenville, North Carolina, United States

Site Status

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Dakota Cancer Institute at Innovis Health - Dakota Clinic

Fargo, North Dakota, United States

Site Status

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Columbus Children's Hospital

Columbus, Ohio, United States

Site Status

Children's Medical Center - Dayton

Dayton, Ohio, United States

Site Status

Toledo Children's Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Forum Health-Tod Childrens Hospital

Youngstown, Ohio, United States

Site Status

Children's Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States

Site Status

CCOP - Oklahoma

Tulsa, Oklahoma, United States

Site Status

Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, United States

Site Status

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Site Status

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, United States

Site Status

Doernbecher Children's Hospital at Oregon Health & Science University

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, United States

Site Status

Children's Hospital of Greenville Hospital System

Greenville, South Carolina, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Sioux Valley Hospital at University of South Dakota Medical Center

Sioux Falls, South Dakota, United States

Site Status

East Tennessee State University Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, United States

Site Status

East Tennessee Children's Hospital

Knoxville, Tennessee, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Site Status

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, United States

Site Status

Children's Hospital of Austin

Austin, Texas, United States

Site Status

Medical City Dallas Hospital

Dallas, Texas, United States

Site Status

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Site Status

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, United States

Site Status

Covenant Children's Hospital

Lubbock, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

MBCCOP - South Texas Pediatrics

San Antonio, Texas, United States

Site Status

Methodist Cancer Center at Methodist Specialty and Transplant Hospital

San Antonio, Texas, United States

Site Status

CCOP - Scott and White Hospital

Temple, Texas, United States

Site Status

Center for Cancer Prevention and Care at Scott and White Clinic

Temple, Texas, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States

Site Status

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Site Status

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Site Status

Naval Medical Center, Portsmouth

Portsmouth, Virginia, United States

Site Status

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Carilion Medical Center for Children

Roanoke, Virginia, United States

Site Status

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Group Health Central Hospital

Seattle, Washington, United States

Site Status

Deaconess Medical Center

Spokane, Washington, United States

Site Status

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

Charleston, West Virginia, United States

Site Status

Cabell Huntington Hospital

Huntington, West Virginia, United States

Site Status

West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status

Bellin Memorial Hospital

Green Bay, Wisconsin, United States

Site Status

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, United States

Site Status

St. Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Site Status

Midwest Children's Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Sydney Children's Hospital

Randwick, New South Wales, Australia

Site Status

Children's Hospital at Westmead

Westmead, New South Wales, Australia

Site Status

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Site Status

Royal Children's Hospital

Parkville, Victoria, Australia

Site Status

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Site Status

Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Children's Hospital of Western Ontario

London, Ontario, Canada

Site Status

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, Canada

Site Status

Hopital Sainte Justine

Montreal, Quebec, Canada

Site Status

Centre de Recherche du Centre Hospitalier de l'Universite Laval

Sainte-Foy, Quebec, Canada

Site Status

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Academisch Ziekenhuis Groningen

Groningen, , Netherlands

Site Status

Starship Children's Health

Auckland, , New Zealand

Site Status

Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus

San Juan, , Puerto Rico

Site Status

San Jorge Childrens Hospital

Santurce, , Puerto Rico

Site Status

Swiss Pediatric Oncology Group Bern

Bern, , Switzerland

Site Status

Swiss Pediatric Oncology Group Geneva

Geneva, , Switzerland

Site Status

Swiss Pediatric Oncology Group Lausanne

Lausanne, , Switzerland

Site Status

Countries

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United States Australia Canada Netherlands New Zealand Puerto Rico Switzerland

Other Identifiers

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COG-AREN04B1

Identifier Type: OTHER

Identifier Source: secondary_id

UTSMC-0390080

Identifier Type: -

Identifier Source: secondary_id

CDR0000366933

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-00417

Identifier Type: REGISTRY

Identifier Source: secondary_id

AREN04B1

Identifier Type: -

Identifier Source: org_study_id

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