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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 . (GENSARC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847691
First Posted: February 19, 2009
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose
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.

Condition
Sarcoma

Study Type: Observational
Study Design: Observational Model: Case-Only
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 .

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Biospecimen Retention:   Samples With DNA
sarcoma biopsy

Enrollment: 350
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sarcoma
patients with biopsy or excision of sarcoma (suspected or diagnosed)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a strong clinical and histological suspicion of sarcoma
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847691


Locations
France
Departement de Pathologie de l'Institut Bergonié
Bordeaux, France, 33076
Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille
Lille, France, 59037
Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard
Lyon, France, 69373
Laboratoire de Génétique des Tumeurs Solides
Nice, France, 06000
Institut Curie
Paris Cedex 5, France, 75248
Service d'Anatomo-Pathologie, Centre Paul Strauss
Strasbourg, France, 67065
Unité de Biologie Moléculaire, CHU de Hautepierre
Strasbourg, France, 67098
Département de biologie et de pathologie médicales, Institut Gustave roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
National Cancer Institute, France
Investigators
Principal Investigator: Florence PEDEUTOUR, PhD Laboratoire de Génétique des Tumeurs Solides
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00847691     History of Changes
Other Study ID Numbers: PSTIC GENSARC
First Submitted: February 18, 2009
First Posted: February 19, 2009
Last Update Posted: December 18, 2012
Last Verified: February 2009

Keywords provided by Centre Hospitalier Universitaire de Nice:
economic evaluation
diagnostics
sarcoma

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