Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

Study Overview
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Brief Summary
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The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Detailed Description
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Subjects will have been recently diagnosed with untreated melanoma. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

Official Title
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Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Other: Blood Sample Collection


Participation Criteria
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Eligibility Criteria
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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 based on skin exam or imaging. 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Melanoma<br>Subjects with clinically confirmed melanoma or high suspicion of a primary malignancy of melanoma based on skin exam or imaging and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection<br>* Subjects participating in the study will have blood drawn at enrollment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood-based biomarkers associated with genetic and epigenetic alterations. | Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with melanoma at the pre-intervention stage. | Point in time blood collection (1 day) at enrollment |