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Completed

NCT Number: NCT01202786

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ha'emek Medical Center, Afula, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. cost-effectiveness

    Time frame: 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 outcomes

  1. compare the diagnostic performance

    Time frame: 18 months

    • Evaluating the miRview™ mets results based on the clinical and pathological work-up in all patients (retrospectively).
    • Evaluating the concordance between miRview™ mets result and the diagnosis obtained by the standard work-up process.
    • Comparing the response to treatment between study groups.
    • Comparing overall survival between study groups

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Collaborators

  • Clalit Health Services
  • Rosetta Genomics

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 16, 2010
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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