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
  Purpose

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.).


Condition
Paediatric Osteosarcomas

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Presence of molecular abnormalities statistically linked to survival or response to chemotherapy

Study Start Date: March 2003
Study Completion Date: August 2011
  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients under 20 years of age with primary osteosarcomas

Criteria

Inclusion Criteria:

  • Patients under 20 years of age with primary osteosarcomas
  • Under treatment by the French Society of Paediatric Oncology OS 94 protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223184

Locations
France
Service de Pédiatrie 3, Hôpital de Hautepierre
Strasbourg, France, 67098
Laboratoire de Biologie Moléculaire, Hôpital de Hautepierre
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Annie BOILLETOT-BABIN, MD Service de Pédiatrie 3, Hôpital de Hautepierre
  More Information

No publications provided

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00223184     History of Changes
Other Study ID Numbers: 2472
Study First Received: September 13, 2005
Last Updated: August 29, 2011
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on July 26, 2014