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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01202786

Enrollment

Registered

2010-09-16

Start date

2010-05-31

Completion date

2012-04-30

Last updated

2012-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Unknown Primary

Keywords

Cancer of Unknown Primary Site (CUP)

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
cost-effectiveness	18 months	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

Secondary

Measure	Time frame	Description
compare the diagnostic performance	18 months	1. Evaluating the miRview™ mets results based on the clinical and pathological work-up in all patients (retrospectively). 2. Evaluating the concordance between miRview™ mets result and the diagnosis obtained by the standard work-up process. 3. Comparing the response to treatment between study groups. 4. Comparing overall survival between study groups

Countries

Israel

Outcome results