NCT00344799

Brief 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. Analysis of the data may identify genetic features that are indicative of prognostic factors including risk of metastasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2020

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

15.8 years

First QC Date

June 26, 2006

Last Update Submit

March 25, 2021

Conditions

Choroidal Melanoma

Keywords

Choroidal MelanomaChoroidal Malignant MelanomaOcular MelanomaUveal Melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with ocular melanoma, and underwent melanoma treatment at our facility.

You may qualify if:

  • 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

You may not qualify if:

  • Patient who refuses local melanoma treatment
  • Patient who refuses to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

    PMID: 20688739DERIVED

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Officials

  • Tara M McCannel, MD, PhD

    Jules Stein Eye Institute, UCLA

    PRINCIPAL INVESTIGATOR

  • Bradley R Straatsma, MD, JD

    Jules Stein Eye Institute, UCLA

    STUDY DIRECTOR

  • Lynn Gordon, MD, PhD

    Jules Stein Eye Institute, UCLA

    STUDY CHAIR

  • Ben Glasgow, MD

    Jules Stein Eye Institute, UCLA

    STUDY CHAIR

  • Nagesh P Rao, PhD

    UCLA Pathology and Laboratory Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

January 8, 2005

Primary Completion

October 23, 2020

Study Completion

October 23, 2020

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations

US(1)