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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091091
Recruitment Status : Completed
First Posted : September 8, 2004
Last Update Posted : February 14, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

Condition or disease Intervention/treatment
Long-term Effects Secondary to Cancer Therapy in Children Lymphoma Other: medical chart review Other: questionnaire administration Procedure: management of therapy complications

Detailed Description:


  • 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.

Study Type : Observational
Actual Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-Related Outcomes For Hodgkin's Disease Survivors
Study Start Date : December 2004
Actual Primary Completion Date : June 27, 2011

Group/Cohort Intervention/treatment
All patients
Self report/Medical record review/ clinical eval
Other: medical chart review Other: questionnaire administration Procedure: management of therapy complications

Primary Outcome Measures :
  1. 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 ]
    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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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.


  • 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



  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091091

United States, California
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 95798
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-9786
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Debra L. Friedman, MD, MS Vanderbilt-Ingram Cancer Center

Responsible Party: Children's Oncology Group Identifier: NCT00091091     History of Changes
Other Study ID Numbers: ALTE04N1
COG-ALTE04N1 ( Other Identifier: Children's Oncology Group )
CDR0000383244 ( Other Identifier: Clinical )
First Posted: September 8, 2004    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Children's Oncology Group:
long-term effects secondary to cancer therapy in children
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases