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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 .

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00847691
First received: February 18, 2009
Last updated: December 17, 2012
Last verified: February 2009
  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

Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00847691     History of Changes
Other Study ID Numbers: PSTIC GENSARC
Study First Received: February 18, 2009
Last Updated: December 17, 2012
Health Authority: France: French Data Protection Authority

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

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

ClinicalTrials.gov processed this record on November 27, 2014