Clinical trial NCT01298388: 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
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Survivor
Leukemia
Long-term Effects Secondary to Cancer Therapy in Children
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2011-02-17
Enrollment: 3138
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no

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.

Eligibility 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

Primary outcomes:
measure: Long-term survival
measure: Disease status
measure: Late adverse effects
measure: Second cancers
measure: Socioeconomic status of survivors
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Regional de la Citadelle
name: Caroline Piette
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Gent
name: Yves Benoit, MD
References:
citation: Rossi G, Kicinski M, Suciu S, Vandecruys E, Plat G, Uyttebroeck A, Paillard C, Barbati M, Dresse MF, Simon P, Minckes O, Pluchart C, Ferster A, Freycon C, Millot F, van der Werff Ten Bosch J, Chantrain C, Paulus R, de Rojas T, de Schaetzen G, Rohrlich P, Benoit Y, Piette C. Fertility status among long-term childhood acute lymphoblastic leukaemia survivors enrolled between 1971 and 1998 in EORTC CLG studies: results of the 58 Late Adverse Effects study. Hum Reprod. 2021 Dec 27;37(1):44-53. doi: 10.1093/humrep/deab236.