Neoplasms, Unknown PrimaryNCT01202786
Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)
An observational study of Neoplasms, Unknown Primary, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Unknown Primary
- How many people
- 60 participants
- Where
- 3 sitesIsrael
- Study dates
- May 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Older than 18 years
- Performance status <2
- life expectancy >3 months
- ANC >1500
- Platelets >100,000 if bone marrow is not involved
Show all 12Show fewer
- Hb > 9
- Creatinine <2
- LFTS < x5 normal
- Histology proven of malignancy
- Enough material for miRview test (10 slices of 10 micrometer sections)
- Member of Clalit HMO
Who cannot join
- Patients unable or unwilling to sign the informed consent form
- Under 18 years old
- Performance status >2
- life expectancy<3 months
- ANC <1500
- Platelets <100,000 if marrow not involved
Show all 10Show fewer
- Hb < 9
- Creatinine >2
- LFTS > x5 normal
- Not member of Clalit HMO
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Ha'emek Medical Center
Afula
Soroka Medical Center
Beersheba
Rabin Medical Center
Petah Tikva, 49100
About this study
Official title: An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel
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.
Read the 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.
- Conditions
- Neoplasms, Unknown Primary
- Keywords
- Cancer of Unknown Primary Site (CUP)
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Unknown PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services, Rosetta Genomics
- Responsible party
- Sponsor
- Investigators
- Salomon Shtemmer, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202786
- Sponsor's protocol ID
- ONCO1miRviewmets
- Status last verified
- Aug 2012
- First submitted
- 14 Sep 2010
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel
- ClinicalTrials.gov ID
- NCT01202786
- Acronym / sponsor ID
- ONCO1miRviewmets
- Conditions
- Neoplasms, Unknown Primary
- Keywords
- Cancer of Unknown Primary Site (CUP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services, Rosetta Genomics
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
- Older than 18 years
- Performance status <2
- life expectancy >3 months
- ANC >1500
Key exclusion criteria (10 listed)
- Patients unable or unwilling to sign the informed consent form
- Under 18 years old
- Performance status >2
- life expectancy<3 months
- ANC <1500
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cost-effectiveness
Time frame: 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
1 secondary outcome
compare the diagnostic performance
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salomon Shtemmer, MD principal investigator
Clalit Health Services
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Unknown Primary, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost-effectiveness (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.