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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms, Unknown Primary

Participation Criteria
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Eligibility Criteria
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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 ANC >1500 Platelets >100,000 if bone marrow is not involved Hb > 9 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 ANC <1500 Platelets <100,000 if marrow not involved Hb < 9 Creatinine >2 LFTS > x5 normal Not member of Clalit HMO

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| miRview mets Disclosed<br>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 | |
| Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness | 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 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the diagnostic performance | 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 | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of Unknown Primary Site (CUP)