- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324609
Detection of Choroidal Nevus Cells in Vitrectomy Fluid
July 7, 2020 updated by: Darius M. Moshfeghi, Stanford University
The purpose of this study is to determine if the investigators can detect the presence of choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and classification of choroidal nevi and melanomas in the future.
Study Overview
Status
Terminated
Conditions
Detailed Description
Approximately 7% of the population has a choroidal nevus, or "freckle," in the back of the eye.
Like a nevus on the skin, there is potential for malignant change to a melanoma.
Dermatologists have the ability to quickly and easily biopsy suspicious skin lesions while ophthalmologists currently have no way of determining the malignant potential of choroidal nevi other than a fine needle aspiration (which is invasive and has the potential complications of bleeding and retinal detachment).
This study's sole aim is to see if choroidal nevi cells are present in the inside fluid of the eye.
The investigators plan to analyze the fluid of the eye, which is routinely removed during retina surgery, to detect any nevus cells.
If the investigators are able to detect these cells, then future studies may allow us to better classify choroidal nevi for potential malignant change.
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication.
Description
Inclusion Criteria:
- Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication (such as epiretinal membrane or macular hole repair).
Exclusion Criteria:
- Patients without a choroidal nevus
- Children under the age of 18
- Pregnant and nursing females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive identification of nevus cells in eye fluid
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Darius M. Moshfeghi, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 25, 2011
First Submitted That Met QC Criteria
March 28, 2011
First Posted (Estimate)
March 29, 2011
Study Record Updates
Last Update Posted (Actual)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-03242011-7564
- IRB-18580
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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