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
1 other identifier
observational
350
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2009
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 18, 2012
February 1, 2009
3 years
February 18, 2009
December 17, 2012
Conditions
Keywords
Study Arms (1)
Sarcoma
patients with biopsy or excision of sarcoma (suspected or diagnosed)
Eligibility Criteria
Patients with a strong clinical and histological suspicion of sarcoma
You may qualify if:
- patients with biopsy or excision of sarcoma (suspected or diagnosed)
- sampling reviewed by pathologists
- frozen sampling
- clinical data available
You may not qualify if:
- opposition of patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Departement de Pathologie de l'Institut Bergonié
Bordeaux, 33076, France
Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille
Lille, 59037, France
Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard
Lyon, 69373, France
Laboratoire de Génétique des Tumeurs Solides
Nice, 06000, France
Institut Curie
Paris, 75248, France
Service d'Anatomo-Pathologie, Centre Paul Strauss
Strasbourg, 67065, France
Unité de Biologie Moléculaire, CHU de Hautepierre
Strasbourg, 67098, France
Département de biologie et de pathologie médicales, Institut Gustave roussy
Villejuif, 94805, France
Biospecimen
sarcoma biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence PEDEUTOUR, PhD
Laboratoire de Génétique des Tumeurs Solides
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2012
Study Completion
July 1, 2012
Last Updated
December 18, 2012
Record last verified: 2009-02