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


N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms, Unknown Primary

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

cost-effectiveness

Outcome Description:

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

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Salomon Shtemmer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clalit Health Services

Authority:

Israel: Ministry of Health

Study ID:

ONCO1miRviewmets

NCT ID:

NCT01202786

Start Date:

May 2010

Completion Date:

April 2012

Related Keywords:

  • Neoplasms, Unknown Primary
  • Cancer of Unknown Primary Site (CUP)
  • Neoplasms
  • Neoplasms, Unknown Primary

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