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

This study has been completed.
Sponsor:
Collaborators:
Clalit Health Services
Rosetta Genomics
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01202786
First received: September 14, 2010
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition
Neoplasms, Unknown Primary

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • cost-effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • compare the diagnostic performance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

Formalin Fixed Paraffin Embedded tumor tissue


Enrollment: 60
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202786

Locations
Israel
Ha'emek Medical Center
Afula, Israel
Soroka Medical Center
Beer-Sheva, Israel
Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Teva Pharmaceutical Industries
Clalit Health Services
Rosetta Genomics
Investigators
Principal Investigator: Salomon Shtemmer, MD Clalit Health Services
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01202786     History of Changes
Other Study ID Numbers: ONCO1miRviewmets
Study First Received: September 14, 2010
Last Updated: August 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Teva Pharmaceutical Industries:
Cancer of Unknown Primary Site (CUP)

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014