Choroidal MelanomaNCT00344799
Cytogenetic Study of Ocular Melanoma
An observational study of Choroidal Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
Patients who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation surgery consent to participate in the study. A tumor sample taken during surgery is studied in the lab for genetic features. These features and features of subjects' clinical course are recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2005to 23 Oct 2020
- 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 have been diagnosed with ocular melanoma, and underwent melanoma treatment at our facility.
Who may be able to join
- Patient with diagnosis of ocular melanoma
- Patient with local treatment plan for ocular melanoma- plaque brachytherapy or enucleation
- Patient 18 years of age or older
- Archival enucleation specimens with diagnosis of ocular melanoma
Who cannot join
- Patient who refuses local melanoma treatment
- Patient who refuses to participate in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Jules Stein Eye Institute
Los Angeles, California, 90095
About this study
Official title: Molecular and Cytogenetic Studies of Ocular Melanoma
Patients who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation surgery consent to participate in the study. A tumor sample taken during surgery is studied in the lab for genetic features. These features and features of subjects' clinical course are recorded. Analysis of the data may identify genetic features that are indicative of prognostic factors including risk of metastasis.
Read the detailed description
The Jules Stein Eye Institute Ocular Melanoma Research Group is conducting cytogenetic studies of choroidal melanoma to improve the screening of biopsy samples of choroidal melanoma through cytogenetic analysis. Our goal is to identify molecular probes that specifically target regions of chromosomes that undergo changes characteristic of metastatic choroidal melanoma.
- Conditions
- Choroidal Melanoma
- Keywords
- Choroidal Melanoma, Choroidal Malignant Melanoma, Ocular 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 posted27 Jun 2006 (estimated)
- Study start8 Jan 2005
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
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 Choroidal 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara M McCannel, MD, PhD, Principal investigator, Jules Stein Eye Institute, UCLABradley R Straatsma, MD, JD, Study director, Jules Stein Eye Institute, UCLALynn Gordon, MD, PhD, Study chair, Jules Stein Eye Institute, UCLABen Glasgow, MD, Study chair, Jules Stein Eye Institute, UCLANagesh P Rao, PhD, Study chair, UCLA Pathology and Laboratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344799
- Sponsor's protocol ID
- UCLA IRB#04-12-084
- Other IDs
- 11-000847
- Status last verified
- Mar 2021
- First submitted
- 26 Jun 2006
- Last updated
- 29 Mar 2021
- Results posted
- No
Publications
McCannel TA, Burgess BL, Nelson SF, Eskin A, Straatsma BR. Genomic identification of significant targets in ciliochoroidal melanoma. Invest Ophthalmol Vis Sci. 2011 May 9;52(6):3018-22. doi: 10.1167/iovs.10-5864.
PubMed 20688739
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Cytogenetic Studies of Ocular Melanoma
- ClinicalTrials.gov ID
- NCT00344799
- Acronym / sponsor ID
- UCLA IRB#04-12-084
- Conditions
- Choroidal Melanoma
- Keywords
- Choroidal Melanoma, Choroidal Malignant Melanoma, Ocular Melanoma, Uveal Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Jan 2005 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 27 Jun 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 who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation surgery consent to participate in the study. A tumor sample taken during surgery is studied in the lab for genetic features. These features and features of subjects' clinical course are recorded. Analysis of the data may identify genetic features that are indicative of prognostic factors including risk of metastasis.
Detailed description
The Jules Stein Eye Institute Ocular Melanoma Research Group is conducting cytogenetic studies of choroidal melanoma to improve the screening of biopsy samples of choroidal melanoma through cytogenetic analysis. Our goal is to identify molecular probes that specifically target regions of chromosomes that undergo changes characteristic of metastatic choroidal melanoma.
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
- Patients who have been diagnosed with ocular melanoma, and underwent melanoma treatment at our facility.
Key inclusion criteria (4 listed)
- Patient with diagnosis of ocular melanoma
- Patient with local treatment plan for ocular melanoma- plaque brachytherapy or enucleation
- Patient 18 years of age or older
- Archival enucleation specimens with diagnosis of ocular melanoma
Key exclusion criteria (2 listed)
- Patient who refuses local melanoma treatment
- Patient who refuses to participate in 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 29 Mar 2021.
- Derived from this study: PubMed 20688739McCannel TA, Burgess BL, Nelson SF, Eskin A, Straatsma BR. Genomic identification of significant targets in ciliochoroidal melanoma. Invest Ophthalmol Vis Sci. 2011 May 9;52(6):3018-22. doi: 10.1167/iovs.10-5864.
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Active, not recruitingObservational study
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Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
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Active, not recruitingPhase 3
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
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RecruitingPhase 3
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
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Enrolling by invitationObservational study
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
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 M McCannel, MD, PhD principal investigator
Jules Stein Eye Institute, UCLA
Bradley R Straatsma, MD, JD study director
Jules Stein Eye Institute, UCLA
Lynn Gordon, MD, PhD study chair
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 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 4 inclusion and 2 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 29 Mar 2021. 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?
On the ClinicalTrials.gov record for NCT00344799, 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 29 Mar 2021.