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
Recruitment status was Not yet recruiting
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.
Long-term Effects Secondary to Cancer Therapy in Children
Other: medical chart review
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
|Official Title:||Assessment of the Long Term Outcome of Childhood ALL Patients Enrolled in EORTC Children's Leukemia Group Trials Between 1971 and 1998|
- 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 ]
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298388
|Study Chair:||Caroline Piette||Centre Hospitalier Regional de la Citadelle|
|Investigator:||Yves Benoit, MD||Universitair Ziekenhuis Gent|