ROSG & TEVA must have a good relationship already...
This study is ongoing, but not recruiting participants.
First Received on September 14, 2010. Last Updated on February 16, 2012 History of Changes
Sponsor: Teva Pharmaceutical Industries
Collaborators: Clalit Health Services
Rosetta Genomics
Information provided by (Responsible Party): Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01202786
Purpose
The aim of the study is in cancer of unknown primary (CUP) patients, to compare the cost-effectiveness of miRview™ mets test with conventional work-up in identifying the primary tumor site.
Condition
Neoplasms, Unknown Primary
Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel
Resource links provided by NLM:
MedlinePlus related topics: Cancer
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
cost-effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To compare the cost-effectiveness of miRview™ mets test with conventional work-up in cancer of unknown primary (CUP) patients, by comparing total cost and time of the diagnostic process (including hospitalization time) from day 1 of the study to the decision on treatment program
Secondary Outcome Measures:
compare the diagnostic performance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Evaluating the miRview™ mets results based on the clinical and pathological work-up in all patients (retrospectively).
Evaluating the concordance between miRview™ mets result and the diagnosis obtained by the standard work-up process.
Comparing the response to treatment between study groups.
Comparing overall survival between study groups
