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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

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ClinicalTrials.gov Identifier: NCT01298388
Recruitment Status : Unknown
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2011
Last Update Posted : September 16, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment
Cancer Survivor Leukemia Long-term Effects Secondary to Cancer Therapy in Children Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables

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.


Study Type : Observational
Estimated Enrollment : 3138 participants
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 Start Date : July 2011
Estimated Primary Completion Date : March 2013





Primary Outcome Measures :
  1. Long-term survival
  2. Disease status
  3. Late adverse effects
  4. Second cancers
  5. Socioeconomic status of survivors


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298388


Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Caroline Piette Centre Hospitalier Regional de la Citadelle
OverallOfficial: Yves Benoit, MD Universitair Ziekenhuis Gent

ClinicalTrials.gov Identifier: NCT01298388     History of Changes
Other Study ID Numbers: CDR0000695273
EORTC-58LAE
EU-21106
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: September 16, 2011
Last Verified: September 2011

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases