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Genetic Characterisation of High-grade Paediatric Osteosarcomas

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00223184
First received: September 13, 2005
Last updated: August 29, 2011
Last verified: August 2011

September 13, 2005
August 29, 2011
March 2003
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Presence of molecular abnormalities statistically linked to survival or response to chemotherapy
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Complete list of historical versions of study NCT00223184 on ClinicalTrials.gov Archive Site
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Genetic Characterisation of High-grade Paediatric Osteosarcomas
Study of Prognostic Value by Molecular Analysis in Paediatric Osteosarcomas of the Chromosomal Regions Containing Rb, p16, p53, Cycline D1, APC, erbB2 and C-met Genes

At present, the only recognised prognostic factor for primary high-grade osteosarcoma is the histological response to preoperative chemotherapy. Our study was designed to identify new diagnostic markers that could eventually have a prognostic value and therapeutic consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while under treatment by the French Society of Paediatric Oncology OS 94 protocol. Paired normal and biopsy samples were collected. In addition, surgical resection specimens, following preoperative chemotherapy, were obtained in many cases. After genomic DNA extraction, an allelotyping analysis targeting microsatellites was planned. The studied DNA regions contained mainly Rb, p53, APC, p16, c-met, TWIST, c-kit, erbB2 and topoisomerases genes. The techniques used in this molecular analysis comprised mainly allelotyping study, quantitative real-time PCR, gene sequencing , immunohistochemistry. The first results showed the prognostic value of 7q31 region containing c-met and 5q21 containing APC (Br J Cancer, 2003, Entz-Werlé et al.), 7p21 containing TWIST (Int J Cancer, 2005, Entz-Werlé et al.) and 4q21 targeting c-kit gene (J Clin Oncol, 2005, Entz-Werlé et al.).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients under 20 years of age with primary osteosarcomas

Paediatric Osteosarcomas
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2011
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Inclusion Criteria:

  • Patients under 20 years of age with primary osteosarcomas
  • Under treatment by the French Society of Paediatric Oncology OS 94 protocol
Both
up to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00223184
2472
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Emmanuel LAVOUE, Directeur Adjoint, University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
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Principal Investigator: Annie BOILLETOT-BABIN, MD Service de Pédiatrie 3, Hôpital de Hautepierre
University Hospital, Strasbourg, France
August 2011

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