Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)
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|ClinicalTrials.gov Identifier: NCT01202786|
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : August 15, 2012
|Condition or disease|
|Neoplasms, Unknown Primary|
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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||April 2012|
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
- cost-effectiveness [ Time Frame: 18 months ]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 ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202786
|Ha'emek Medical Center|
|Soroka Medical Center|
|Rabin Medical Center|
|Petah Tikva, Israel, 49100|
|Principal Investigator:||Salomon Shtemmer, MD||Clalit Health Services|