NCT01298388

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,138

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

September 16, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

February 16, 2011

Last Update Submit

September 15, 2011

Conditions

Keywords

long-term effects secondary to cancer therapy in childrencancer survivorrecurrent childhood acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemiaT-cell childhood acute lymphoblastic leukemianon-T, non-B childhood acute lymphoblastic leukemianon-T, non-B, cALLa positive childhood acute lymphoblastic leukemianon-T, non-B, cALLa negative childhood acute lymphoblastic leukemianon-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemiachildhood acute lymphoblastic leukemia in remission

Outcome Measures

Primary Outcomes (5)

  • Long-term survival

  • Disease status

  • Late adverse effects

  • Second cancers

  • Socioeconomic status of survivors

Interventions

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Caroline Piette

    Centre Hospitalier Regional de la Citadelle

    STUDY CHAIR
  • Yves Benoit, MD

    University Ghent

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Last Updated

September 16, 2011

Record last verified: 2011-09