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Study of Long-Term Outcomes of Patients With Acute Lymphoblastic Leukemia Who Were Enrolled as Children on Clinical Trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 Between 1971 and 1998

Primary Purpose

Cancer Survivor, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
medical chart review
questionnaire administration
study of socioeconomic and demographic variables
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cancer Survivor focused on measuring long-term effects secondary to cancer therapy in children, cancer survivor, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, non-T, non-B childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive childhood acute lymphoblastic leukemia, non-T, non-B, cALLa negative childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Patients with acute lymphoblastic leukemia (ALL) previously enrolled as children (less than18 years of age at diagnosis) on any of the following clinical trials between 1971 and 1998:

    • EORTC-58741
    • EORTC-58831
    • EORTC-58832
    • EORTC-58881

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Long-term survival
    Disease status
    Late adverse effects
    Second cancers
    Socioeconomic status of survivors

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2011
    Last Updated
    September 15, 2011
    Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01298388
    Brief Title
    Study of Long-Term Outcomes of Patients With Acute Lymphoblastic Leukemia Who Were Enrolled as Children on Clinical Trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 Between 1971 and 1998
    Official Title
    Assessment of the Long Term Outcome of Childhood ALL Patients Enrolled in EORTC Children's Leukemia Group Trials Between 1971 and 1998
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    September 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    March 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Studying medical records and collecting questionnaires from patients who were enrolled as children in clinical trials for acute lymphoblastic leukemia may help doctors learn about long-term effects of treatment and plan the best treatment. PURPOSE: This clinical trial is studying the long-term outcomes of patients with acute lymphoblastic leukemia who were enrolled as children on clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 between 1971 and 1998.
    Detailed Description
    OBJECTIVES: To assess the long-term outcomes (i.e., long-term survival, long-term disease status, occurrence of late adverse effects, occurrence of second cancers, and socioeconomic status of survivors) of patients with acute lymphoblastic leukemia previously enrolled as children on clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 between the years of 1971 and 1998. OUTLINE: Long-term outcome data are collected from the databases about clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881. Other data collected include the patient's vital status actualization (e.g., alive, dead or lost to follow up, date last known to be alive or date of death), medical records data, and the collection of data from patients confirmed to be alive (e.g., data related to marital status, education, work, insurance, puberty, fertility, and offspring) by questionnaire.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Survivor, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children
    Keywords
    long-term effects secondary to cancer therapy in children, cancer survivor, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, non-T, non-B childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive childhood acute lymphoblastic leukemia, non-T, non-B, cALLa negative childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission

    7. Study Design

    Enrollment
    3138 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    medical chart review
    Intervention Type
    Other
    Intervention Name(s)
    questionnaire administration
    Intervention Type
    Other
    Intervention Name(s)
    study of socioeconomic and demographic variables
    Primary Outcome Measure Information:
    Title
    Long-term survival
    Title
    Disease status
    Title
    Late adverse effects
    Title
    Second cancers
    Title
    Socioeconomic status of survivors

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Patients with acute lymphoblastic leukemia (ALL) previously enrolled as children (less than18 years of age at diagnosis) on any of the following clinical trials between 1971 and 1998: EORTC-58741 EORTC-58831 EORTC-58832 EORTC-58881 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caroline Piette
    Organizational Affiliation
    Centre Hospitalier Regional de la Citadelle
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Yves Benoit, MD
    Organizational Affiliation
    Universitair Ziekenhuis Gent

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34788455
    Citation
    Rossi G, Kicinski M, Suciu S, Vandecruys E, Plat G, Uyttebroeck A, Paillard C, Barbati M, Dresse MF, Simon P, Minckes O, Pluchart C, Ferster A, Freycon C, Millot F, van der Werff Ten Bosch J, Chantrain C, Paulus R, de Rojas T, de Schaetzen G, Rohrlich P, Benoit Y, Piette C. Fertility status among long-term childhood acute lymphoblastic leukaemia survivors enrolled between 1971 and 1998 in EORTC CLG studies: results of the 58 Late Adverse Effects study. Hum Reprod. 2021 Dec 27;37(1):44-53. doi: 10.1093/humrep/deab236.
    Results Reference
    derived

    Learn more about this trial

    Study of Long-Term Outcomes of Patients With Acute Lymphoblastic Leukemia Who Were Enrolled as Children on Clinical Trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 Between 1971 and 1998

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