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

N/ACompletedNCT01202786

Teva Branded Pharmaceutical Products R&D, Inc.60 enrolled

Overview

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.

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

Enrollment

Conditions

Neoplasms, Unknown Primary

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Older than 18 years 3. Performance status \<2 4. life expectancy \>3 months 5. ANC \>1500 6. Platelets \>100,000 if bone marrow is not involved 7. Hb \> 9 8. Creatinine \<2 9. LFTS \< x5 normal 10. Histology proven of malignancy 11. Enough material for miRview test (10 slices of 10 micrometer sections) 12. Member of Clalit HMO Exclusion Criteria: 1. Patients unable or unwilling to sign the informed consent form 2. Under 18 years old 3. Performance status \>2 4. life expectancy\<3 months 5. ANC \<1500 6. Platelets \<100,000 if marrow not involved 7. Hb \< 9 8. Creatinine \>2 9. LFTS \> x5 normal 10. Not member of Clalit HMO

Locations (3)

Ha'emek Medical Center

Afula, Israel

Soroka Medical Center

Beersheba, Israel

Rabin Medical Center

Petah Tikva, Israel

Outcomes

Primary Outcomes

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

Time frame: 18 months

Secondary Outcomes

compare the diagnostic performance

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

Time frame: 18 months

Data from ClinicalTrials.gov

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