SarcomaGENSARCNCT00847691
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 .
An observational study of Sarcoma, run by Centre Hospitalier Universitaire de Nice at 8 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- How many people
- 350 participants
- Where
- 8 sitesFrance
- Study dates
- Mar 2009to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a strong clinical and histological suspicion of sarcoma
Who may be able to join
- patients with biopsy or excision of sarcoma (suspected or diagnosed)
- sampling reviewed by pathologists
- frozen sampling
- clinical data available
Who cannot join
- opposition of patient
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Departement de Pathologie de l'Institut Bergonié
Bordeaux, 33076
Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille
Lille, 59037
Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard
Lyon, 69373
Laboratoire de Génétique des Tumeurs Solides
Nice, 06000
Institut Curie
Paris, 75248
Service d'Anatomo-Pathologie, Centre Paul Strauss
Strasbourg, 67065
Unité de Biologie Moléculaire, CHU de Hautepierre
Strasbourg, 67098
Département de biologie et de pathologie médicales, Institut Gustave roussy
Villejuif, 94805
About this study
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.
- Conditions
- Sarcoma
- Keywords
- economic evaluation, diagnostics, sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoma | patients with biopsy or excision of sarcoma (suspected or diagnosed) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Florence PEDEUTOUR, PhD, Principal investigator, Laboratoire de Génétique des Tumeurs Solides
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847691
- Sponsor's protocol ID
- PSTIC GENSARC
- Acronym
- GENSARC
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT00847691
- Acronym / sponsor ID
- GENSARC / PSTIC GENSARC
- Conditions
- Sarcoma
- Keywords
- economic evaluation, diagnostics, sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Mar 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcoma | – | –patients with biopsy or excision of sarcoma (suspected or diagnosed) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a strong clinical and histological suspicion of sarcoma
Key inclusion criteria (4 listed)
- patients with biopsy or excision of sarcoma (suspected or diagnosed)
- sampling reviewed by pathologists
- frozen sampling
- clinical data available
Key exclusion criteria (1 listed)
- opposition of patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence PEDEUTOUR, PhD principal investigator
Laboratoire de Génétique des Tumeurs Solides
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Centre Hospitalier Universitaire de Nice at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.