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

Teva Pharmaceuticals

Status: Completed

Conditions: Neoplasms, Unknown Primary

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01202786

ONCO1miRviewmets

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

miRview mets Disclosed

Description:

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

Description:

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