GENSARC 2008 : Medical Economic Evaluation of the Molecular Detection by FISH (Fluorescent in Situ Hybridization) and by PCR (Polymerase Chain Reaction) of Sarcomas Specific Translocations and Amplifications .

Sarcoma Clinical Trial

— GENSARC  

Official title:

GENSARC 2008 : Medical Economic Evaluation of the Molecular Detection by FISH (Fluorescent in Situ Hybridization) and by PCR (Polymerase Chain Reaction) of Sarcomas Specific Translocations and Amplifications .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847691
• Other study ID #: PSTIC GENSARC
• Status: Completed
• Phase: N/A
• First received: February 18, 2009
• Last updated: December 17, 2012
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

The clinical and histological diagnosis of sarcomas is often very difficult. The identification of chromosomal and molecular anomalies, such as amplifications, deletions or fusion genes is a powerful help for establishing a correct diagnosis of sarcomas and their benign counterparts. However, the cost of the cytogenetic and molecular techniques for the detection of these alterations is often a limitation to their use. The aim of our study is to evaluate the direct cost of the molecular techniques in comparison to the cost that would be generated by an appropriate therapy and care management of the patient in case of an erroneous diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with biopsy or excision of sarcoma (suspected or diagnosed)

• sampling reviewed by pathologists

• frozen sampling

• clinical data available

Exclusion Criteria:

• opposition of patient

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Sarcoma

Locations

Country	Name	City	State
France	Departement de Pathologie de l'Institut Bergonié	Bordeaux
France	Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille	Lille
France	Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard	Lyon
France	Laboratoire de Génétique des Tumeurs Solides	Nice
France	Institut Curie	Paris Cedex 5
France	Service d'Anatomo-Pathologie, Centre Paul Strauss	Strasbourg
France	Unité de Biologie Moléculaire, CHU de Hautepierre	Strasbourg
France	Département de biologie et de pathologie médicales, Institut Gustave roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	National Cancer Institute, France

Country where clinical trial is conducted

France,