Mesothelioma, Small Cell Lung Cancer, NSCLCMiCK AssayNCT01770665
Validation of the MiCK Assay
An observational study of Mesothelioma, Small Cell Lung Cancer, NSCLC, run by Pierian Biosciences at 1 site in United States.
Trial summary
Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mesothelioma, Small Cell Lung Cancer, NSCLC
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2016
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.
Who may be able to join
- 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.
Who cannot join
- patients that a sample cannot obtained for testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Validation Support Services 3050 Superior Drive NW
Rochester, Minnesota, 55901
About this study
Official title: Mayo Clinic Validation of the MiCK Assay
Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.
Read the detailed description
This study will be conducted in two phases.
During the Feasibility Phase, specimens from any tumor will be sent to the central DiaTech MiCK assay laboratory to determine the ease of sample acquisition, processing, transport, and assay interpretation.
Once DiaTech has completed analyses for the feasibility phase specimens and has confirmed that the sample acquisition, processing, transport, and assay interpretation are appropriate, we will proceed with the Demonstration Phase.
During the Mesothelioma Demonstration Phase, 20 mesothelioma samples will be assayed and the results will be correlated with prior patient therapy, performance status, and extent of disease.
- Medical subject headings
- Mesothelioma, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| Mesothelioma | Not described | |
| all cancer types | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response and survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionSep 2016
Why it stopped: Assay being revised and re-validated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesothelioma, Small Cell Lung Cancer, NSCLCStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pierian Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Karaus, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770665
- Sponsor's protocol ID
- MAYO1000
- Acronym
- MiCK Assay
- Status last verified
- Sep 2016
- First submitted
- 16 Jan 2013
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Clinic Validation of the MiCK Assay
- ClinicalTrials.gov ID
- NCT01770665
- Acronym / sponsor ID
- MiCK Assay / MAYO1000
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Assay being revised and re-validated.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Pierian BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Jan 2013 (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.
Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.
Detailed description
This study will be conducted in two phases.
During the Feasibility Phase, specimens from any tumor will be sent to the central DiaTech MiCK assay laboratory to determine the ease of sample acquisition, processing, transport, and assay interpretation.
Once DiaTech has completed analyses for the feasibility phase specimens and has confirmed that the sample acquisition, processing, transport, and assay interpretation are appropriate, we will proceed with the Demonstration Phase.
During the Mesothelioma Demonstration Phase, 20 mesothelioma samples will be assayed and the results will be correlated with prior patient therapy, performance status, and extent of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesothelioma | – | – |
| all cancer types | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.
Key inclusion criteria (1 listed)
- 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.
Key exclusion criteria (1 listed)
- patients that a sample cannot obtained for testing.
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
Complete response and survival
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Assay being revised and re-validated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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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.
Mary Karaus study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesothelioma, Small Cell Lung Cancer, NSCLC, run by Pierian Biosciences at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Assay being revised and re-validated.). Results are not available in the source record.
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?
Complete response and survival (time frame: 1 year). 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 16 Sep 2016.