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

Neoplasms, Unknown Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202786
• Other study ID #: ONCO1miRviewmets
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: August 14, 2012
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms, Unknown Primary

Locations

Country	Name	City	State
Israel	Ha'emek Medical Center	Afula
Israel	Soroka Medical Center	Beer-Sheva
Israel	Rabin Medical Center	Petah Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries	Clalit Health Services, Rosetta Genomics

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	compare the diagnostic performance	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	18 months	No