Uveal MelanomaCLEARNCT02376920
5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes
An observational study of Uveal Melanoma, run by Castle Biosciences Incorporated.
Trial summary
Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Uveal Melanoma
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Apr 2022
- How long will I take part?
- 10 Years
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with uveal melanoma and determined by their treating physician to be appropriate for DecisionDx-UM testing.
Who may be able to join
- Patients with a diagnosis of Uveal Melanoma
- Patients whose physician deems them appropriate for DecisionDx-UM testing
- Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data
Who cannot join
- Patients with any other form of cancer
About this study
Official title: CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.
Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.
- Conditions
- Uveal Melanoma
- Keywords
- occular melanoma, melanoma of eye, DecisionDx-UM
- Medical subject headings
- Uveal Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern
Measured: Approximately 3-6 weeks after biopsy of uveal tumor
Time to metastasis
Measured: Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
Secondary outcomes (1)
changes in health care costs
review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing
Measured: Patients followed for up to 10 years at 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2010
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uveal MelanomaStudies 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
- 93 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Castle Biosciences Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Cook, PhD, Principal investigator, Castle Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376920
- Sponsor's protocol ID
- 2-01
- Acronym
- CLEAR
- Status last verified
- May 2022
- First submitted
- 13 Feb 2015
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Plasseraud KM, Cook RW, Tsai T, Shildkrot Y, Middlebrook B, Maetzold D, Wilkinson J, Stone J, Johnson C, Oelschlager K, Aaberg TM. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study. J Oncol. 2016;2016:5325762. doi: 10.1155/2016/5325762. Epub 2016 Jun 30.
PubMed 27446211
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.
- ClinicalTrials.gov ID
- NCT02376920
- Acronym / sponsor ID
- CLEAR / 2-01
- Conditions
- Uveal Melanoma
- Keywords
- occular melanoma, melanoma of eye, DecisionDx-UM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Castle Biosciences IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 3 Mar 2015 (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.
Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with uveal melanoma and determined by their treating physician to be appropriate for DecisionDx-UM testing.
Key inclusion criteria (3 listed)
- Patients with a diagnosis of Uveal Melanoma
- Patients whose physician deems them appropriate for DecisionDx-UM testing
- Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data
Key exclusion criteria (1 listed)
- Patients with any other form of cancer
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
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
Time frame: Approximately 3-6 weeks after biopsy of uveal tumor
Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern
Time to metastasis
Time frame: Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
1 secondary outcome
changes in health care costs
Time frame: Patients followed for up to 10 years at 6 month intervals
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 16 May 2022.
- Derived from this study: PubMed 27446211Plasseraud KM, Cook RW, Tsai T, Shildkrot Y, Middlebrook B, Maetzold D, Wilkinson J, Stone J, Johnson C, Oelschlager K, Aaberg TM. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study. J Oncol. 2016;2016:5325762. doi: 10.1155/2016/5325762. Epub 2016 Jun 30.
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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.
Robert Cook, PhD principal investigator
Castle Biosciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveal Melanoma, run by Castle Biosciences Incorporated.
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 3 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: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay (time frame: Approximately 3-6 weeks after biopsy of uveal tumor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02376920, which also lists 1 linked publication.
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 May 2022.