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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00223184

Enrollment

Unknown

Registered

2005-09-22

Start date

2003-03-31

Completion date

2011-08-31

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric Osteosarcomas

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.).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 20 Years

Healthy volunteers

Inclusion criteria

* Patients under 20 years of age with primary osteosarcomas * Under treatment by the French Society of Paediatric Oncology OS 94 protocol

Design outcomes

Primary

Measure	Time frame
Presence of molecular abnormalities statistically linked to survival or response to chemotherapy	—

Countries

France

Outcome results