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
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|
- 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|
- Long-term survival
- Disease status
- Late adverse effects
- Second cancers
- Socioeconomic status of survivors
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
|Study Chair:||Caroline Piette||Centre Hospitalier Regional de la Citadelle|
|OverallOfficial:||Yves Benoit, MD||Universitair Ziekenhuis Gent|