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

NCT ID: NCT01298388

Last Updated: 2011-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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

Interventions

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medical chart review

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

study of socioeconomic and demographic variables

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Principal Investigators

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Caroline Piette

Role: STUDY_CHAIR

Centre Hospitalier Regional de la Citadelle

Yves Benoit, MD

Role:

University Ghent

References

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de Ville de Goyet M, Kicinski M, Suciu S, Vandecruys E, Uyttebroeck A, Ferster A, Freycon C, Plat G, Thomas C, Barbati M, Dresse MF, Paillard C, Pluchart C, Simon P, Chantrain C, Minckes O, van der Werff Ten Bosch J, Bertrand Y, Rohrlich P, Millot F, Paulus R, Benoit Y, Piette C; European Organisation for Research, Treatment of Cancer (EORTC) Children's Leukemia Group (CLG). Long-term neurotoxicity among childhood acute lymphoblastic leukaemia survivors enrolled between 1971 and 1998 in EORTC Children Leukemia Group studies. Discov Oncol. 2024 Jan 29;15(1):20. doi: 10.1007/s12672-024-00869-6.

Reference Type DERIVED
PMID: 38285235 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34788455 (View on PubMed)

Other Identifiers

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EORTC-58LAE

Identifier Type: -

Identifier Source: secondary_id

EU-21106

Identifier Type: -

Identifier Source: secondary_id

CDR0000695273

Identifier Type: -

Identifier Source: org_study_id

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