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

13. juli 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

530

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Palo Alto, California, Forenede Stater, 95798
        • Lucile Packard Children's Hospital at Stanford University Medical Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520-8028
        • Yale Cancer Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center Cancer Center
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229-3039
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-9786
        • Children's Hospital of Philadelphia
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105
        • St. Jude Children's Research Hospital
      • Nashville, Tennessee, Forenede Stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Children's Hospital and Regional Medical Center - Seattle
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
All patients
Self report/Medical record review/ clinical eval
Andet: medicinsk diagram gennemgang
Andet: spørgeskemaadministration
Procedure: behandling af terapikomplikationer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Debra L. Friedman, MD, MS, Vanderbilt-Ingram Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2004

Primær færdiggørelse (Faktiske)

27. juni 2011

Studieafslutning

7. december 2022

Datoer for studieregistrering

Først indsendt

7. september 2004

Først indsendt, der opfyldte QC-kriterier

7. september 2004

Først opslået (Skøn)

8. september 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2018

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALTE04N1
  • COG-ALTE04N1 (Anden identifikator: Children's Oncology Group)
  • CDR0000383244 (Anden identifikator: Clinical Trials.gov)
  • NCI-2009-00381 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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