Combination Chemotherapy in Treating Children With Progressive Brain Tumors
NCT ID: NCT00002944
Last Updated: 2013-09-09
Study Results
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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COMPLETED
PHASE3
428 participants
INTERVENTIONAL
1997-04-30
2012-04-30
Brief Summary
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PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.
Detailed Description
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* Compare the event free survival as a result of treatment with carboplatin and vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children with progressive brain tumors.
* Estimate tumor response rates to each regimen of chemotherapy in these patients.
* Determine toxic effects and quality of life of children treated with each regimen of chemotherapy.
* Investigate biological and clinical factors which may predict tumor response and early progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative index by MIB-1 (Ki67)) in these patients.
* Investigate factors contributing to neuropsychological and endocrine status of children with brain tumors treated without irradiation.
OUTLINE: This is a randomized study. Patients are stratified according to site of disease, status at entry, and pathology. Patients are randomized to one of two treatment arms. Patients with neurofibromatosis are nonrandomly assigned to arm II.
* Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance beginning on day 84 of induction or upon hematopoietic recovery. Each course consists of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently with the first 3 weeks of carboplatin), followed by 2 weeks of rest.
* Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4, followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a maximum of 8 courses.
PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regimen A (CV Chemotherapy)
Induction will consist of 10 weeks of therapy (carboplatin, vincristine sulfate),followed by 2 weeks without chemotherapy. Induction should only be interrupted in the event of grade 3 neurotoxicity, grade 2 renal toxicity, grade 4 hematologic toxicity, or tumor progression. Maintenance-Four Courses (2 cycles/course) commences on Day 84 (week 12) of Induction or when peripheral counts recover with ANC \>1,000/$L and platelet count \>100,000/$L. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine sulfate (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.
carboplatin
Given IV
vincristine sulfate
Given PO and IV
Regimen B (TPCV Chemotherapy)
Each cycle of chemotherapy consists of 4 days of oral chemotherapy (Thioguanine, procarbazine hydrochloride, Lomustine and Vincristine sulfate beginning Day 0, followed by vincristine sulfate IV on Days 14 and 28. The cycle is repeated every 6 weeks (42 days). A total of 8 cycles will be given.
lomustine
Given IV
procarbazine hydrochloride
Given PO
thioguanine
Given PO
vincristine sulfate
Given PO and IV
Interventions
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carboplatin
Given IV
lomustine
Given IV
procarbazine hydrochloride
Given PO
thioguanine
Given PO
vincristine sulfate
Given PO and IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Astrocytic tumors
* Low grade astrocytoma (variants: fibrillary, protoplasmic, gemistocytic)
* Pilocytic astrocytoma
* Pleomorphic xanthoastrocytomas
* Subependymal giant cell astrocytoma
* Infantile desmoplastic astrocytoma
* Low grade oligodendroglial tumors
* Low grade oligodendroglioma
* Low grade mixed gliomas
* Oligo-astrocytoma
* Neuronal Tumors
* Ganglioglioma (excluding tumors with anaplastic astrocytic components)
* Infantile desmoplastic ganglioglioma
* Chiasmatic-hypothalamic tumor without histologic confirmation
* All of the following diagnostic tests (radiological or clinical evidence of progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of enrollment into this study
* Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (less than 95% or greater than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic impairment with progression
* Chiasmatic lesions that have contiguous extensions of tumor into other regions of the visual pathways demonstrated on contrast MRI will be eligible for study without histopathological confirmation
* Patients with neurofibromatosis who have radiographic diagnosis of chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy confirmation of tumor histology, but not unless tumor progression is documented radiographically
* No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without definitive involvement of the optic chiasm
PATIENT CHARACTERISTICS:
Age:
* Under 10
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3 (arm II)
* Platelet count greater than 100,000/mm\^3 (arm II)
Hepatic:
* Not specified
Renal:
* Creatinine less than 1.5 times upper limit of normal for age OR
* Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as determined by the institutional normal range
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for the tumor
Endocrine therapy:
* Prior corticosteroid therapy allowed
Radiotherapy:
* No prior radiotherapy for the tumor
Surgery:
* See Disease characteristics
Other:
* Prior diuretic therapy allowed
9 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Joann Ater, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital and Research Center Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Santa Barbara Cottage Children's Hospital
Santa Barbara, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Keyser Family Cancer Center at Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, United States
Simmons Cooper Cancer Institute
Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program at Barbara Bush Children's Hospital
Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Hospitals and Clinics of Minnesota - St. Paul
Saint Paul, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Keesler Air Force Base Medical Center
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Children's Hospital
Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States
Overlook Hospital
Morristown, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Albany Medical Center Hospital
Albany, New York, United States
Maimonides Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Beth Israel Medical Center - Petrie Division
New York, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Dakota Cancer Institute at Dakota Clinic - South University
Fargo, North Dakota, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's - Dayton
Dayton, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
Tod Children's Hospital
Youngstown, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
John Hunter Hospital
Newcastle, New South Wales, Australia
Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec
Québec, , Canada
University Medical Center Groningen
Groningen, , Netherlands
Starship Children's Health
Auckland, , New Zealand
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva, , Switzerland
Countries
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References
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Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. doi: 10.1200/JCO.2011.36.6054. Epub 2012 Jun 4.
Other Identifiers
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CCG-A9952
Identifier Type: OTHER
Identifier Source: secondary_id
POG-A9952
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-9952
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000065394
Identifier Type: OTHER
Identifier Source: secondary_id
A9952
Identifier Type: -
Identifier Source: org_study_id