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| Name | Class |
|---|---|
| Clalit Health Services | OTHER |
| Rosetta Genomics | UNKNOWN |
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The aim of the study is in cancer of unknown primary (CUP) patients, to compare the cost-effectiveness of miRviewâ„¢ 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. miRviewâ„¢ mets is a new molecular diagnostic tool that identifies the tissue-of-origin of metastatic tumors, with 90% sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| miRview mets Disclosed | Patients of group 1 will be submitted to the standard conventional work-up (see below) as well as miRviewâ„¢ mets assay. Their physician will treat the patient based upon both results | ||
| Control | Patients of group 2 will be submitted to the standard conventional work-up. miRviewâ„¢ 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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| Measure | Description | Time Frame |
|---|---|---|
| cost-effectiveness | To compare the cost-effectiveness of miRviewâ„¢ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| compare the diagnostic performance |
| 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Salomon Shtemmer, MD | Clalit Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ha'emek Medical Center | Afula | Israel | ||||
| Soroka Medical Center |
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| ID | Term |
|---|---|
| D009382 | Neoplasms, Unknown Primary |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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Formalin Fixed Paraffin Embedded tumor tissue
| Beersheba |
| Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| D013568 |
| Pathological Conditions, Signs and Symptoms |