Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

NCT ID: NCT00736749

Last Updated: 2025-07-23

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

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-17

Brief Summary

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This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

Detailed Description

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PRIMARY OBJECTIVES:

I. To develop a mechanism for tracking and retaining patients enrolled on Children's Oncology Group (COG) protocols.

II. To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported quality of life and health status.

III. To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC).

IV. To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution.

V. To facilitate collection of protocol-specific outcome data through collaboration with the LTFC Oversight Committee, the SDC, and the member institutions.

OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.

Within 3 months of enrollment on ALTE05N1, patients receive a packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, secure online form, or 24-hour toll-free telephone number. After initial contact, the LTFC will contact the patient annually.

Conditions

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Hematopoietic Cell Transplantation Recipient Leukemia Solid Tumor

Study Groups

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Observational (long-term follow-up)

Within 3 months of enrollment on ALTE05N1, patients receive a packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, secure online form, or 24-hour toll-free telephone number. After initial contact, the LTFC will contact the patient annually

Assessment of Therapy Complications

Intervention Type PROCEDURE

Complete patient response form and Health Status Update Form

Questionnaire Administration

Intervention Type OTHER

Complete patient response form, Health Status Update Form (called the "Keep in Touch" form), and Quality of Life Questionnaire (PROMIS)

Interventions

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Assessment of Therapy Complications

Complete patient response form and Health Status Update Form

Intervention Type PROCEDURE

Questionnaire Administration

Complete patient response form, Health Status Update Form (called the "Keep in Touch" form), and Quality of Life Questionnaire (PROMIS)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient must reside in the U.S. on the date of enrollment to ALTE05N1
* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Smita Bhatia

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status RECRUITING

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status ACTIVE_NOT_RECRUITING

USA Health Strada Patient Care Center

Mobile, Alabama, United States

Site Status RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

The University of Arizona Medical Center-University Campus

Tucson, Arizona, United States

Site Status RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Kaiser Permanente Downey Medical Center

Downey, California, United States

Site Status RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status SUSPENDED

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Site Status RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Mattel Children's Hospital UCLA

Los Angeles, California, United States

Site Status RECRUITING

Valley Children's Hospital

Madera, California, United States

Site Status RECRUITING

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status RECRUITING

Children's Hospital of Orange County

Orange, California, United States

Site Status RECRUITING

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Site Status RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, United States

Site Status RECRUITING

UCSF Medical Center-Parnassus

San Francisco, California, United States

Site Status ACTIVE_NOT_RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

Site Status RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Site Status RECRUITING

MedStar Georgetown University Hospital

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

Site Status RECRUITING

Children's National Medical Center

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

Site Status RECRUITING

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Lee Memorial Health System

Fort Myers, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status RECRUITING

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Miami Cancer Institute

Miami, Florida, United States

Site Status RECRUITING

Florida Hospital Orlando

Orlando, Florida, United States

Site Status RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic - Orlando

Orlando, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Nemours Children's Hospital

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Site Status SUSPENDED

Saint Mary's Hospital

West Palm Beach, Florida, United States

Site Status RECRUITING

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, United States

Site Status RECRUITING

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status RECRUITING

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

Site Status RECRUITING

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, United States

Site Status RECRUITING

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status RECRUITING

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States

Site Status RECRUITING

Blank Children's Hospital

Des Moines, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status ACTIVE_NOT_RECRUITING

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status ACTIVE_NOT_RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Floating Hospital for Children at Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Site Status RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Columbia Regional

Columbia, Missouri, United States

Site Status RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status RECRUITING

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status RECRUITING

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Site Status RECRUITING

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Morristown Medical Center

Morristown, New Jersey, United States

Site Status RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status SUSPENDED

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States

Site Status RECRUITING

Overlook Hospital

Summit, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

NYU Winthrop Hospital

Mineola, New York, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

New York Medical College

Valhalla, New York, United States

Site Status RECRUITING

Mission Hospital Inc-Memorial Campus

Asheville, North Carolina, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Dayton Children's Hospital

Dayton, Ohio, United States

Site Status RECRUITING

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, United States

Site Status RECRUITING

Mercy Children's Hospital

Toledo, Ohio, United States

Site Status SUSPENDED

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, United States

Site Status RECRUITING

Legacy Emanuel Children's Hospital

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status SUSPENDED

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, United States

Site Status RECRUITING

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States

Site Status RECRUITING

Greenville Cancer Treatment Center

Greenville, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

T C Thompson Children's Hospital

Chattanooga, Tennessee, United States

Site Status SUSPENDED

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

Site Status RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Site Status RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Site Status RECRUITING

Medical City Dallas Hospital

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Children's Hospital of San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Site Status RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Site Status RECRUITING

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Site Status RECRUITING

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

Site Status RECRUITING

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status RECRUITING

West Virginia University Charleston Division

Charleston, West Virginia, United States

Site Status RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

San Jorge Children's Hospital

San Juan, , Puerto Rico

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Puerto Rico

Facility Contacts

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800-388-8721

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602-546-0920

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520-626-9008

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510-891-3400

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800-826-4673

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310-423-8965

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877-642-4691

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916-734-3089

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203-785-5702

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954-355-5346

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800-599-2456

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407-303-2090

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312-355-3046

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888-226-4343

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317-338-2194

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617-636-5535

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336-713-6771

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216-844-5437

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419-824-1842

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800-811-8480

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800-622-8922

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800-782-8581

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414-955-4727

Other Identifiers

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NCI-2009-00382

Identifier Type: REGISTRY

Identifier Source: secondary_id

PALTE05N1_A06PAMDREVW01

Identifier Type: -

Identifier Source: secondary_id

CDR0000590123

Identifier Type: -

Identifier Source: secondary_id

ALTE05N1

Identifier Type: OTHER

Identifier Source: secondary_id

ALTE05N1

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180886

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1CA189955

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1CA189958

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ALTE05N1

Identifier Type: -

Identifier Source: org_study_id

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