Second Malignant Neoplasms After Childhood ALL Therapy

NCT ID: NCT01476462

Last Updated: 2012-05-24

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

COMPLETED

Total Enrollment

642 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.

Detailed Description

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To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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ALL diagnosed 1980-2007

Cases of childhood acute lymphoblastic leukemia (ALL) diagnosed between 1980 and 2007 and included in the clinical trials of the participating ALL study groups

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with childhood acute lymphoblastic leukemia
* Diagnosis of second cancer before December 31st 2007

Exclusion Criteria

* Uncertainty if the second cancer has emerged from the same original leukemic clone
Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordic Society for Pediatric Hematology and Oncology

OTHER

Sponsor Role collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

ALL-BFM Study Group

NETWORK

Sponsor Role collaborator

Dutch Childhood Oncology Group

OTHER

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role collaborator

United Kingdom Children's Cancer Study Group

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kjeld Schmiegelow

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kjeld Schmiegelow, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Maria G Valsecchi, M.Sci,

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di medicina clinica e prevenzione, University of Milan, Italy

Locations

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Kjeld Schmiegelow

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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PdL SMN Study 1

Identifier Type: -

Identifier Source: org_study_id

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