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 .
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centre Hospitalier Universitaire de Nice
Collaborator:
National Cancer Institute, France
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00847691
First received: February 18, 2009
Last updated: April 11, 2011
Last verified: February 2009
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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
| Estimated Enrollment: | 350 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847691
Contacts
| Contact: Florence PEDEUTOUR, PhD | 04 93 37 70 12 | florence.pedeutour@unice.fr |
Locations
| France | |
| Departement de Pathologie de l'Institut Bergonié | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Jean Michel Coindre, Pr 05 56 33 33 26 | |
| Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille | Recruiting |
| Lille, France, 59037 | |
| Contact: Fabienne Escande, Dr 03 20 44 61 54 | |
| Sub-Investigator: Xavier LEROY, Dr | |
| Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard | Recruiting |
| Lyon, France, 69373 | |
| Principal Investigator: Dominique Ranchere-Vince, Dr | |
| Sub-Investigator: Anne Valérie De Couvelaere, Dr | |
| Laboratoire de Génétique des Tumeurs Solides | Recruiting |
| Nice, France, 06000 | |
| Contact: Florence Pedeutour, PhD florence.pedeutour@unice.fr | |
| Principal Investigator: Florence Pedeutour, PhD | |
| Institut Curie | Recruiting |
| Paris Cedex 5, France, 75248 | |
| Contact: Olivier Delattre, Dr 01 42 34 67 21 | |
| Sub-Investigator: Jérôme COUTURIER, Dr | |
| Sub-Investigator: Alain AURIAS, Dr | |
| Sub-Investigator: Marik Lae, Dr | |
| Service d'Anatomo-Pathologie, Centre Paul Strauss | Recruiting |
| Strasbourg, France, 67065 | |
| Principal Investigator: Jean-Pierre GHNASSIA, Dr | |
| Unité de Biologie Moléculaire, CHU de Hautepierre | Recruiting |
| Strasbourg, France, 67098 | |
| Principal Investigator: Anne Claire Voegeli, Dr | |
| Département de biologie et de pathologie médicales, Institut Gustave roussy | Recruiting |
| Villejuif, France, 94805 | |
| Principal Investigator: Philippe Terrier, Dr | |
| Sub-Investigator: Jean Benard, Dr | |
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: | Departement de la Recherche Clinique et de l'Innovation, 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: | April 11, 2011 |
| 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, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on September 26, 2012
