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Second Malignant Neoplasms After Childhood ALL Therapy (PdL-SMN1)

This study has been completed.
Sponsor:
Collaborators:
Nordic Society for Pediatric Hematology and Oncology
European Organisation for Research and Treatment of Cancer - EORTC
Dana-Farber Cancer Institute
ALL-BFM Study Group
Dutch Childhood Oncology Group
St. Jude Children's Research Hospital
United Kingdom Children's Cancer Study Group
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01476462
First received: July 13, 2011
Last updated: May 23, 2012
Last verified: May 2012

July 13, 2011
May 23, 2012
January 2009
April 2011   (final data collection date for primary outcome measure)
  • Pattern of SMN subtypes [ Time Frame: At 20 years from diagnosis ] [ Designated as safety issue: No ]
    Pattern of the main groups of SMN and their clinical charactiristics
  • Overall survival by subtype [ Time Frame: At 10 years from diagnosis of SMN ] [ Designated as safety issue: No ]
    Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)
  • Risk factors for development of SMN [ Time Frame: At 20 years from ALL diagnosis ] [ Designated as safety issue: No ]
    Identification of risk factors linked to the interval to SMN, the subtype of SMN, and the survival after. These risk factors are clinical characteristics of ALL or the anti-ALL therapy administered
Same as current
Complete list of historical versions of study NCT01476462 on ClinicalTrials.gov Archive Site
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Second Malignant Neoplasms After Childhood ALL Therapy
Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

The study cohort includes all registered cases of second cancers occurring as the first event among children diagnosed with acute lymphoblastic leukemia and treated according to protocol by one of the collaborative groups participating in the present study

Acute Lymphoblastic Leukemia
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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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
642
December 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
up to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01476462
PdL SMN Study 1
No
Kjeld Schmiegelow, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • Nordic Society for Pediatric Hematology and Oncology
  • European Organisation for Research and Treatment of Cancer - EORTC
  • Dana-Farber Cancer Institute
  • ALL-BFM Study Group
  • Dutch Childhood Oncology Group
  • St. Jude Children's Research Hospital
  • United Kingdom Children's Cancer Study Group
Principal Investigator: Kjeld Schmiegelow, M.D. Rigshospitalet, Denmark
Principal Investigator: Maria G Valsecchi, M.Sci, Dipartimento di medicina clinica e prevenzione, University of Milan, Italy
Rigshospitalet, Denmark
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP