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

May 23, 2012 updated by: Kjeld Schmiegelow, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

642

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Kjeld Schmiegelow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of SMN subtypes
Time Frame: At 20 years from diagnosis
Pattern of the main groups of SMN and their clinical charactiristics
At 20 years from diagnosis
Overall survival by subtype
Time Frame: At 10 years from diagnosis of SMN
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
Time Frame: At 20 years from ALL diagnosis
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Dana-Farber Cancer Institute
St. Jude Children's Research Hospital
European Organisation for Research and Treatment of Cancer - EORTC
Nordic Society for Pediatric Hematology and Oncology
ALL-BFM Study Group
Dutch Childhood Oncology Group
United Kingdom Children's Cancer Study Group

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

May 24, 2012

Last Update Submitted That Met QC Criteria

May 23, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PdL SMN Study 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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