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Health-Related Outcomes For Hodgkin's Disease Survivors


N/A
N/A
N/A
Open (Enrolling)
Both
Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma

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Trial Information

Health-Related Outcomes For Hodgkin's Disease Survivors


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Debra L. Friedman, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000383244

NCT ID:

NCT00091091

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Long-term Effects Secondary to Cancer Therapy in Children
  • Lymphoma
  • 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
  • Hodgkin Disease
  • Lymphoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Chicago Cancer Research CenterChicago, Illinois  60637
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032