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

• Conditions: Cancer Survivor; Leukemia; Long-term Effects Secondary to Cancer Therapy in Children

• Registration Number: NCT01298388
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

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 Timeline

• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Study Start: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-15
• Last Update Posted: 2011-09-16
• Primary Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term survival
Disease status
Late adverse effects
Second cancers
Socioeconomic status of survivors