An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- cost-effectiveness
Study Overview
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 Description
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who present with histologically-confirmed metastatic cancer in whom an initial work-up which consists of detailed medical history, physical examination, basic laboratory studies, histopathological review of biopsy material, and CT scan of the chest abdomen and pelvis fail to identify the primary site.
- •Older than 18 years
- •Performance status <2
- •life expectancy >3 months
- •Platelets >100,000 if bone marrow is not involved
- •Creatinine <2
- •LFTS < x5 normal
- •Histology proven of malignancy
- •Enough material for miRview test (10 slices of 10 micrometer sections)
- •Member of Clalit HMO
Exclusion Criteria
- •Patients unable or unwilling to sign the informed consent form
- •Under 18 years old
- •Performance status >2
- •life expectancy<3 months
- •Platelets <100,000 if marrow not involved
- •Creatinine >2
- •LFTS > x5 normal
- •Not member of Clalit HMO
Outcomes
Primary Outcomes
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
Secondary Outcomes
- compare the diagnostic performance(18 months)