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Genetic Characterisation of High-grade Paediatric Osteosarcomas

NCT ID: NCT00223184

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Study Completion Date

2011-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Paediatric Osteosarcomas

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Strasbourg, France

Principal Investigators

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Annie BOILLETOT-BABIN, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Pédiatrie 3, Hôpital de Hautepierre

Locations

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Laboratoire de Biologie Moléculaire, Hôpital de Hautepierre

Strasbourg, , France

Site Status

Service de Pédiatrie 3, Hôpital de Hautepierre

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2472

Identifier Type: -

Identifier Source: org_study_id

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