Collaborative Ocular Oncology Group Uveal Melanoma Validation Study Number 2 (COOG2)

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to assess the claim that a gene named PRAME (Preferentially expressed Antigen in Melanoma) can be used as a class one tumor metastases predictor in a large group of patients who have uveal melanoma.  

Eligibility Criteria:

Ages Eligible for Study: 18 and above

Sexes Eligible for Study: All genders

Accepts healthy Volunteers: (Yes/No)  No

Inclusion Criteria

1) Patients at least 18 years of age.

2) Pre-operative diagnosis of UM with clinical exam documenting tumor size and location.

3) Concurrent tumor biopsy for standard of care performed just prior to I-125 brachytherapy plaque (or proton beam irradiation) or taken post-enucleation.

4) Clinical DecisionDx-UM testing performed by Castle.

 

Patients who have been previously enucleated or had their tumor resected could be included assuming tissue (either FFPE or fresh frozen) is available, or has been previously tested, using the DecisionDx-UM assay.  

Exclusion Criteria

1) Patients who are high risk of complications from tumor resection (e.g. bleeding, anti-coagulant therapy) as part of standard of care.

2) Patients who have had any form of treatment for their UM prior to DecisionDx-UM testing.

 

IRB 40305