Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)
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.
Neoplasms, Unknown Primary
|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|
- 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
- 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
Biospecimen Retention: Samples Without DNA
Formalin Fixed Paraffin Embedded tumor tissue
|Study Start Date:||May 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
miRview mets Disclosed
Patients of group 1 will be submitted to the standard conventional work-up (see below) as well as miRview™ mets assay. Their physician will treat the patient based upon both results
Patients of group 2 will be submitted to the standard conventional work-up. miRview™ mets assay will be performed but will remain blinded for both the patient and referring physician. Treatment will be decided based on standard work-up results
Thousands of patients are diagnosed each year with metastatic cancer; however, about 3-5% of them are diagnosed with Cancer of Unknown Primary (CUP). In order to identify the optimal treatment plan for individual patients with CUP, the primary tumor site must be identified. Patients undergo a wide range of costly, time-consuming, and inefficient tests to identify the primary site of origin, often to no avail.
In this era of targeted therapies, the accurate diagnosis of the primary tumor can be crucial. miRview™ mets is a new molecular diagnostic tool that identifies the tissue-of-origin of metastatic tumors, with 90% sensitivity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202786
|Ha'emek Medical Center|
|Soroka Medical Center|
|Rabin Medical Center|
|Petah Tikva, Israel, 49100|
|Principal Investigator:||Salomon Shtemmer, MD||Clalit Health Services|