NCT00847691

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 18, 2012

Status Verified

February 1, 2009

Enrollment Period

3 years

First QC Date

February 18, 2009

Last Update Submit

December 17, 2012

Conditions

Keywords

economic evaluationdiagnosticssarcoma

Study Arms (1)

Sarcoma

patients with biopsy or excision of sarcoma (suspected or diagnosed)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille

Lille, 59037, France

Location

Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard

Lyon, 69373, France

Location

Laboratoire de Génétique des Tumeurs Solides

Nice, 06000, France

Location

Institut Curie

Paris, 75248, France

Location

Service d'Anatomo-Pathologie, Centre Paul Strauss

Strasbourg, 67065, France

Location

Unité de Biologie Moléculaire, CHU de Hautepierre

Strasbourg, 67098, France

Location

Département de biologie et de pathologie médicales, Institut Gustave roussy

Villejuif, 94805, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

sarcoma biopsy

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Florence PEDEUTOUR, PhD

    Laboratoire de Génétique des Tumeurs Solides

    PRINCIPAL INVESTIGATOR

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

Locations