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Clinical Trials (PDQ®)

Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyClosedAny age; 21 and under at diagnosisNCI, OtherALTE04N1
COG-ALTE04N1, CDR0000383244, NCT00091091

Trial Description

Summary

RATIONALE: Assessing the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.

PURPOSE: This clinical trial is studying the long-term effects of treatment in patients who were previously treated for childhood Hodgkin's lymphoma.

Further Study Information

OBJECTIVES:

  • 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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Debra L. FriedmanPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00091091
ClinicalTrials.gov processed this data on August 07, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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