Clinical trial NCT01202786: Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)
Official title: An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Unknown Primary
Keywords: Cancer of Unknown Primary Site (CUP)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
name: Rosetta Genomics
First posted: 2010-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: cost-effectiveness
timeFrame: 18 months
Secondary outcomes:
measure: compare the diagnostic performance
timeFrame: 18 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'emek Medical Center
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Clalit Health Services
name: Salomon Shtemmer, MD
role: PRINCIPAL_INVESTIGATOR
References: