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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Afula, Israel
        • Ha'Emek Medical Center
      • Beer-Sheva, Israel
        • Soroka Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the diagnostic performance
Time Frame: 18 months
  1. Evaluating the miRview™ mets results based on the clinical and pathological work-up in all patients (retrospectively).
  2. Evaluating the concordance between miRview™ mets result and the diagnosis obtained by the standard work-up process.
  3. Comparing the response to treatment between study groups.
  4. Comparing overall survival between study groups
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Salomon Shtemmer, MD, Clalit Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

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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