Clinical Trial: Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Teva Pharmaceutical Industries

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: compare the diagnostic performance [ Time Frame: 18 months ]

  1. Evaluating the miRview™ mets results based on the clinical and pathological work-up in all patients (retrospectively).
  2. Evaluating the concordance between miRview™ mets result and the diagnosis obtained by the standard work-up process.
  3. Comparing the response to treatment between study groups.
  4. Comparing overall survival between study groups


Original Secondary Outcome: Same as current

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: September 14, 2010
Date Started: May 2010
Date Completion:
Last Updated: August 14, 2012
Last Verified: August 2012