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

Completed

• Conditions: Neoplasms, Unknown Primary

• Registration Number: NCT01202786
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cost-effectiveness	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 Outcome Measures

Name	Time	Method
compare the diagnostic performance	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

Trial Locations

Locations (3)

Ha'emek Medical Center; 🇮🇱 Afula, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Soroka Medical Center; 🇮🇱 Beer-Sheva, Israel