We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298388
First Posted: February 17, 2011
Last Update Posted: September 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Assessment of the Long Term Outcome of Childhood ALL Patients Enrolled in EORTC Children's Leukemia Group Trials Between 1971 and 1998

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Long-term survival
  • Disease status
  • Late adverse effects
  • Second cancers
  • Socioeconomic status of survivors

Estimated Enrollment: 3138
Study Start Date: July 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT01298388     History of Changes
Other Study ID Numbers: CDR0000695273
EORTC-58LAE
EU-21106
First Submitted: February 16, 2011
First Posted: February 17, 2011
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