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

NCT01202786 | Completed

• 1 other identifier: ONCO1miRviewmets
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Neoplasms, Unknown Primary

Keywords

Cancer of Unknown Primary Site (CUP)

Outcome Measures

Primary Outcomes (1)

• cost-effectiveness

  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 Outcomes (1)

• compare the diagnostic performance

  18 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• Clalit Health Services: collaborator
• Rosetta Genomics: collaborator

Study Sites (3)

Ha'emek Medical Center

Afula, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin Fixed Paraffin Embedded tumor tissue

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salomon Shtemmer, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

IL (3)