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

NCT ID: NCT01202786

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Neoplasms, Unknown Primary

Keywords

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Cancer of Unknown Primary Site (CUP)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clalit Health Services

OTHER

Sponsor Role collaborator

Rosetta Genomics

UNKNOWN

Sponsor Role collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salomon Shtemmer, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services

Locations

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Ha'emek Medical Center

Afula, , Israel

Site Status

Soroka Medical Center

Beersheba, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ONCO1miRviewmets

Identifier Type: -

Identifier Source: org_study_id