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BAP1 Testing in Instance Choroidal Nevi or Uveal Melanoma

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ClinicalTrials.gov Identifier: NCT01925599
Recruitment Status : Unknown
Verified August 2016 by Amy C Schefler, MD, Greater Houston Retina Research.
Recruitment status was:  Recruiting
First Posted : August 20, 2013
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Amy C Schefler, MD, Greater Houston Retina Research

Tracking Information
First Submitted Date August 15, 2013
First Posted Date August 20, 2013
Last Update Posted Date August 8, 2016
Study Start Date July 2013
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2013)
Examine the rate of germline BAP1 mutations in young patients, diagnosed with choroidal nevi [ Time Frame: 1 Year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01925599 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BAP1 Testing in Instance Choroidal Nevi or Uveal Melanoma
Official Title Identification of Germline BAP1 Mutation In Subjects With Choroidal Nevi or Uveal Melanoma
Brief Summary The BAP1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal melanoma for a germline BAP1 mutation and other genetic markers associated with developing malignancy as well as additional sequencing of the uveal melanoma genome.
Detailed Description A germline BAP1 mutation predisposes a person to developing uveal melanoma and other cancers. If a mutation is discovered, it changes the potential approach to managing the nevus. In the presence of a known genomic change associated with aggressive disease, closer follow up and more aggressive treatment could preserve the patient's vision and prevent micrometastatic spread. This new screening technique will be able to extend the length and quality of life of patients with more frequent targeted cancer screens.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood
Sampling Method Probability Sample
Study Population Patients age > 18 years, diagnosed with choroidal nevi or uveal melanoma
Condition Choroidal Nevi, Uveal Melanoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 3, 2016)
100
Original Estimated Enrollment
 (submitted: August 15, 2013)
50
Estimated Study Completion Date January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

any person with choroidal nevi

  • Willingness to provide signed informed consent
  • Age > 18 years
  • Diagnosis of choroidal nevi or uveal melanoma

Threre are no exclusionary criteria for this study.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01925599
Other Study ID Numbers BAP101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Amy C Schefler, MD, Greater Houston Retina Research
Study Sponsor Amy C Schefler, MD
Collaborators Not Provided
Investigators
Principal Investigator: Amy C. Schefler, MD Retina Consultants Houston
PRS Account Greater Houston Retina Research
Verification Date August 2016