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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00091091
First received: September 7, 2004
Last updated: August 5, 2014
Last verified: August 2014

September 7, 2004
August 5, 2014
December 2004
June 2013   (final data collection date for primary outcome measure)
Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire [ Time Frame: length of study ] [ Designated as safety issue: No ]
The calculation of the incidence rates will be done in two ways: (a) using the self-report incidence of adverse conditions; and (b) using the incidence of adverse conditions validated by clinical evaluation.
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Complete list of historical versions of study NCT00091091 on ClinicalTrials.gov Archive Site
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Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
Health-Related Outcomes For Hodgkin's Disease Survivors

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Treatment for primary Hodgkin disease at any one of the participating institutions 1987 - onward, or patients otherwise eligible and currently followed at one of the participating institutions.

  • Long-term Effects Secondary to Cancer Therapy in Children
  • Lymphoma
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: management of therapy complications
All patients
Self report/Medical record review/ clinical eval
Interventions:
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: management of therapy complications
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
530
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June 2013   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00091091
ALTE04N1, COG-ALTE04N1, CDR0000383244
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Debra L. Friedman, MD, MS Vanderbilt-Ingram Cancer Center
Children's Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP