Viewing Study NCT00223184



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Study NCT ID: NCT00223184
Status: COMPLETED
Last Update Posted: 2011-08-30
First Post: 2005-09-13

Brief Title: Genetic Characterisation of High-grade Paediatric Osteosarcomas
Sponsor: University Hospital Strasbourg France
Organization: University Hospital Strasbourg France

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2011-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None