Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects.
PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.
연구 개요
상세 설명
OBJECTIVES:
- Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.
OUTLINE: This is a multicenter study.
More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head.
PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Stanford, California, 미국, 94305
- Stanford Comprehensive Cancer Center - Stanford
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Florida
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Miami, Florida, 미국, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, 미국, 33155
- Miami Children's Hospital
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Tampa, Florida, 미국, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, 미국, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Hawaii
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Honolulu, Hawaii, 미국, 95813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush University Medical Center
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Maine
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Bangor, Maine, 미국, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Massachusetts
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Boston, Massachusetts, 미국, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
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Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Mississippi
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Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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St. Louis, Missouri, 미국, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center Cancer Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87131-5636
- University of New Mexico Cancer Research and Treatment Center
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New York
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Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
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North Carolina
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Charlotte, North Carolina, 미국, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Winston-Salem, North Carolina, 미국, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma University Cancer Institute
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Texas
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Houston, Texas, 미국, 77030-2399
- Baylor University Medical Center - Houston
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San Antonio, Texas, 미국, 78207
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Midwest Children's Cancer Center
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Quebec
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Montreal, Quebec, 캐나다, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
DISEASE CHARACTERISTICS:
Previously enrolled on POG-9201 or POG-9605
- Good prognosis by NCI risk (9201 and 9605 stratum 1)
- Eligible for the therapeutic study
- Completed therapy by 12/31/2000
- No CNS3 at diagnosis
- No relapsed disease
PATIENT CHARACTERISTICS:
Age:
- 1 to 9 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No Down syndrome
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85
기간: Length of study
|
Length of study
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Compare the groups for descriptive purposes
기간: Length of study
|
Quantitative scales: IQ (WISC III or WPPSI-R, depending on the age of the child), Wide Range Assessment of Memory and Learning (4 subscales), Conner's Continuous Performance Test (Attention/Concentration), Woodcock Johnson Revised Processing Speed Cluster, NEPSP Tower Tests (Executive Functioning), and VSI (Visual-Motor Integration).
|
Length of study
|
공동 작업자 및 조사자
수사관
- 연구 의자: Patricia K. Duffner, MD, Women & Children's Hospital of Buffalo
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACCL0131
- COG-ACCL0131 (기타 식별자: Children's Oncology Group)
- NCI-P01-0198
- CDR0000069100 (기타 식별자: Clinical Trials.gov)
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