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Trial record 2 of 451 for:    Recruiting, Not yet recruiting, Available Studies | "Nevus"

BAP1 Testing in Instance Choroidal Nevi or Uveal Melanoma

This study is currently recruiting participants.
Verified August 2016 by Amy C Schefler, MD, Greater Houston Retina Research
Sponsor:
ClinicalTrials.gov Identifier:
NCT01925599
First Posted: August 20, 2013
Last Update Posted: August 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Amy C Schefler, MD, Greater Houston Retina Research
  Purpose
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.

Condition
Choroidal Nevi, Uveal Melanoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Germline BAP1 Mutation In Subjects With Choroidal Nevi or Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by Amy C Schefler, MD, Greater Houston Retina Research:

Primary Outcome Measures:
  • Examine the rate of germline BAP1 mutations in young patients, diagnosed with choroidal nevi [ Time Frame: 1 Year ]

Biospecimen Retention:   Samples With DNA
Whole Blood

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients age > 18 years, diagnosed with choroidal nevi or uveal melanoma
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925599


Contacts
Contact: Amy C Schefler, MD 713-524-3434 acsmd@houstonretina.com
Contact: Cassie Cone, BA 713-524-3434 ccone@houstonretina.com

Locations
United States, Texas
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Contact: Cassie Cone, BA    713-524-3434    cassandra.cone@houstonretina.com   
Principal Investigator: Amy C Schefler, MD         
Retina Consultants of Houston Recruiting
Katy, Texas, United States, 77494
Contact: Cassie Cone, BA    713-524-3434    ccone@houstonretina.com   
Principal Investigator: Amy Schefler, MD         
Retina Consultants of Houston Recruiting
The Woodlands, Texas, United States, 77384
Contact: Melisa Bocanegra    713-524-3434    melisa.bocanegra@houstonretina.com   
Principal Investigator: Amy Schefler, MD         
Sponsors and Collaborators
Amy C Schefler, MD
Investigators
Principal Investigator: Amy C. Schefler, MD Retina Consultants Houston
  More Information

Publications:
Responsible Party: Amy C Schefler, MD, Director of Ophthalmic Oncology, Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT01925599     History of Changes
Other Study ID Numbers: BAP101
First Submitted: August 15, 2013
First Posted: August 20, 2013
Last Update Posted: August 8, 2016
Last Verified: August 2016

Keywords provided by Amy C Schefler, MD, Greater Houston Retina Research:
Nevus
Choroidal Melanoma
BAP1 mutation

Additional relevant MeSH terms:
Nevus
Nevi and Melanomas
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases