Status:

COMPLETED

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

Lead Sponsor:

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborating Sponsors:

Clalit Health Services

Rosetta Genomics

Conditions:

Neoplasms, Unknown Primary

Eligibility:

All Genders

18+ years

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 fo...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2012

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT01202786

Start Date

May 1 2010

End Date

April 1 2012

Last Update

August 15 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Ha'emek Medical Center

Afula, Israel

2

Soroka Medical Center

Beersheba, Israel

3

Rabin Medical Center

Petah Tikva, Israel, 49100