Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
NCT ID: NCT00091091
Last Updated: 2018-07-16
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
530 participants
OBSERVATIONAL
2004-12-31
Brief Summary
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PURPOSE: This clinical trial is studying the long-term effects of treatment in patients who were previously treated for childhood Hodgkin's lymphoma.
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Detailed Description
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* Determine the cumulative incidence and characterize the spectrum of selected adverse physiologic and psychosocial outcomes, using self-report and clinical evaluation, in patients previously treated for childhood Hodgkin's lymphoma.
* Compare the cumulative incidence and spectrum of self-reported adverse outcomes of these patients, using data collected at a comparable time period after diagnosis, with Hodgkin's lymphoma survivors from the Childhood Cancer Survivor Study (CCSS).
* Compare self-reported health-related outcomes with outcomes detected by clinical evaluation and medical record review of each group of patients.
OUTLINE: This is a cohort, cross-sectional, multicenter study.
* Contemporary group: Patients complete a self-report of long-term outcomes questionnaire and a comprehensive psychosocial questionnaire. A medical record review is then performed. Patients then undergo a comprehensive risk-based clinical evaluation with specific examinations and studies based upon the Children's Oncology Group Late Effects Screening Guidelines and the patients' specific therapeutic exposures.
* Childhood Cancer Survivor Study (CCSS) group: Patients undergo a telephone interview and have medical records reviewed to validate select self-reported long-term outcomes. Patient replies from the baseline CCSS questionnaire (which was completed at certain timepoints after diagnosis) are reviewed for targeted long-term outcomes.
PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All patients
Self report/Medical record review/ clinical eval
medical chart review
questionnaire administration
management of therapy complications
Interventions
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medical chart review
questionnaire administration
management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* Contemporary cohort
* At least 5 years since diagnosis of Hodgkin's lymphoma
* Diagnosed between the years 1987-2001
* 21 and under at diagnosis
* No evidence of disease
* Prior treatment on 1 of the following protocols during the years 1987-2001:
* Children's Cancer Group (CCG) CCG-5942, CCG-59704
* Pediatric Oncology Group (POG) POG-8625, POG-8725, POG-9425, POG-9426
* Pediatric Hodgkin's Consortium: VAMP, VEPA, VAMP/COP
* Institutional protocols COPP/ABV, MOPP/ABVD, ABVD
* Childhood Cancer Survivor Study (CCSS) Hodgkin's lymphoma cohort
* Current enrollment in the CCSS
* Diagnosed between the years 1976-1986
* Completed baseline questionnaire at comparable timepoints (as the contemporary cohort) after diagnosis
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
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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Debra L. Friedman, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Countries
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Other Identifiers
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COG-ALTE04N1
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000383244
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00381
Identifier Type: REGISTRY
Identifier Source: secondary_id
ALTE04N1
Identifier Type: -
Identifier Source: org_study_id
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