Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  • Subject is male or female > 18 years of age.
  • Subject has an untreated primary melanoma.

  OR

  Subject has high suspicion of primary malignancy of melanoma.

  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

• Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 5 days between biopsy (other than FNA) of target pathology and blood collection.
  • IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.