- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01202786
Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)
An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Afula, Israel
- Ha'Emek Medical Center
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Beer-Sheva, Israel
- Soroka Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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miRview mets Disclosed
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
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Control
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cost-effectiveness
Time Frame: 18 months
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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
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare the diagnostic performance
Time Frame: 18 months
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18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Salomon Shtemmer, MD, Clalit Health Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONCO1miRviewmets
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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