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

European Organisation for Research and Treatment of Cancer (EORTC)

Status: Unknown

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

Treatments: Other: medical chart review; Other: study of socioeconomic and demographic variables; Other: questionnaire administration

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01298388

EORTC-58LAE

EU-21106

CDR0000695273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,138 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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