Second Malignant Neoplasms After Childhood ALL Therapy
PdL-SMN1
1 other identifier
observational
642
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 24, 2012
May 1, 2012
2.2 years
July 13, 2011
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pattern of SMN subtypes
Pattern of the main groups of SMN and their clinical charactiristics
At 20 years from diagnosis
Overall survival by subtype
Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)
At 10 years from diagnosis of SMN
Risk factors for development of SMN
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
At 20 years from ALL diagnosis
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- Diagnosed with childhood acute lymphoblastic leukemia
- Diagnosis of second cancer before December 31st 2007
You may not qualify if:
- Uncertainty if the second cancer has emerged from the same original leukemic clone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Nordic Society for Pediatric Hematology and Oncologycollaborator
- European Organisation for Research and Treatment of Cancer - EORTCcollaborator
- Dana-Farber Cancer Institutecollaborator
- ALL-BFM Study Groupcollaborator
- Dutch Childhood Oncology Groupcollaborator
- St. Jude Children's Research Hospitalcollaborator
- United Kingdom Children's Cancer Study Groupcollaborator
Study Sites (1)
Kjeld Schmiegelow
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 13, 2011
First Posted
November 22, 2011
Study Start
January 1, 2009
Primary Completion
April 1, 2011
Study Completion
December 1, 2011
Last Updated
May 24, 2012
Record last verified: 2012-05