Ocular MelanomaNCT00351728
Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone
An observational study of Ocular Melanoma and Choroidal Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT scans of the whole body are performed at baseline, three months later, and six months after that for a total of three combined scans in the first year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Melanoma, Choroidal Melanoma, Uveal Melanoma
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 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: choroidal melanoma patients
Who may be able to join
- Patients with a diagnosis of ocular melanoma (a pigmented malignant tumor) involving the choroid and/or ciliary body (the blood vessel layer in the back of the eye and/or the part of the eye behind the iris).
- Patients 18 years of age or older.
- Patients able to give informed consent.
Who cannot join
- Patients who refuse to participate in the study.
- Patients who are unable to cooperate with or cannot undergo PET/CT scanning.
- Patients who will be moving out of the area of UCLA during the ten years of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jules Stein Eye Institute
Los Angeles, California, 90095-7000
About this study
Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT scans of the whole body are performed at baseline, three months later, and six months after that for a total of three combined scans in the first year. Subsequently, these combined scans will be performed at 6-monthly intervals for a total of two combined scans per year.
- Conditions
- Ocular Melanoma, Choroidal Melanoma, Uveal Melanoma
- Medical subject headings
- Uveal Melanoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular MelanomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara A McCannel, MD, PhD, Principal investigator, Jules Stein Eye Institute, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351728
- Sponsor's protocol ID
- UCLA IRB #05-04-016
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2006
- Last updated
- 7 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone
- ClinicalTrials.gov ID
- NCT00351728
- Acronym / sponsor ID
- UCLA IRB #05-04-016
- Conditions
- Ocular Melanoma, Choroidal Melanoma, Uveal Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jul 2006 (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.
Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT scans of the whole body are performed at baseline, three months later, and six months after that for a total of three combined scans in the first year. Subsequently, these combined scans will be performed at 6-monthly intervals for a total of two combined scans per year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- choroidal melanoma patients
Key inclusion criteria (3 listed)
- Patients with a diagnosis of ocular melanoma (a pigmented malignant tumor) involving the choroid and/or ciliary body (the blood vessel layer in the back of the eye and/or the part of the eye behind the iris).
- Patients 18 years of age or older.
- Patients able to give informed consent.
Key exclusion criteria (3 listed)
- Patients who refuse to participate in the study.
- Patients who are unable to cooperate with or cannot undergo PET/CT scanning.
- Patients who will be moving out of the area of UCLA during the ten years of this study.
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
Not reported in the source record.
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 7 Jul 2016.
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Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
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Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
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Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
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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.
Tara A McCannel, MD, PhD principal investigator
Jules Stein Eye Institute, UCLA
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 Ocular Melanoma and Choroidal Melanoma, run by Jonsson Comprehensive Cancer Center 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 3 inclusion and 3 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 7 Jul 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 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.
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 7 Jul 2016.