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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01298388
First received: February 16, 2011
Last updated: September 15, 2011
Last verified: September 2011
  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 [ Designated as safety issue: No ]
  • Disease status [ Designated as safety issue: No ]
  • Late adverse effects [ Designated as safety issue: Yes ]
  • Second cancers [ Designated as safety issue: No ]
  • Socioeconomic status of survivors [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298388

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01298388     History of Changes
Other Study ID Numbers: CDR0000695273, EORTC-58LAE, EU-21106
Study First Received: February 16, 2011
Last Updated: September 15, 2011
Health Authority: Unspecified

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
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 19, 2014