Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
13. juli 2018 oppdatert av: Children's Oncology Group
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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
530
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Palo Alto, California, Forente stater, 95798
- Lucile Packard Children's Hospital at Stanford University Medical Center
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06520-8028
- Yale Cancer Center
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60637-1470
- University of Chicago Cancer Research Center
-
-
New Jersey
-
Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center Cancer Center
-
-
New York
-
New York, New York, Forente stater, 10065
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
-
Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104-9786
- Children's Hospital of Philadelphia
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hospital Comprehensive Cancer Center
-
-
Tennessee
-
Memphis, Tennessee, Forente stater, 38105
- St. Jude Children's Research Hospital
-
Nashville, Tennessee, Forente stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Dallas, Texas, Forente stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
-
Washington
-
Seattle, Washington, Forente stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
All patients
Self report/Medical record review/ clinical eval
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire
Tidsramme: 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.
|
length of study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Debra L. Friedman, MD, MS, Vanderbilt-Ingram Cancer Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2004
Primær fullføring (Faktiske)
27. juni 2011
Studiet fullført
7. desember 2022
Datoer for studieregistrering
Først innsendt
7. september 2004
Først innsendt som oppfylte QC-kriteriene
7. september 2004
Først lagt ut (Anslag)
8. september 2004
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juli 2018
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ALTE04N1
- COG-ALTE04N1 (Annen identifikator: Children's Oncology Group)
- CDR0000383244 (Annen identifikator: Clinical Trials.gov)
- NCI-2009-00381 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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