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Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008
First Received: September 7, 2004   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091091
  Purpose

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 Intervention
Cancer-Related Problem/Condition
Lymphoma
Other: medical chart review
Other: questionnaire administration
Procedure: management of therapy complications

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma
U.S. FDA Resources
Study Type: Observational
Official Title: Health-Related Outcomes For Hodgkin's Disease Survivors

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1000
Study Start Date: December 2004
Detailed Description:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091091

Locations
United States, California
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center     650-498-7061     cctoffice@stanford.edu    
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center     203-785-5702        
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, New Jersey
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C     212-305-8615        
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Barbara L. Asselin     585-275-2981        
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021-6094
Contact: Peter G. Steinherz     212-639-7951        
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica     513-636-0161        
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104-9786
Contact: Peter Adamson     215-590-6359        
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18107
Contact: Philip M. Monteleone     484-884-3347        
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C     401-444-1488        
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Clinical Trials Office - St. Jude Children's Research Hospital     901-595-4644        
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a     866-460-4673; 214-648-7097        
United States, Washington
Children's Hospital and Regional Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas Hawkins     206-987-3096        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Debra L. Friedman, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000383244, COG-ALTE04N1
Study First Received: September 7, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00091091     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hodgkin Lymphoma, Childhood
Neoplasm Metastasis
Hodgkin's Disease
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

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

ClinicalTrials.gov processed this record on May 06, 2009