COVID-19

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.

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.

Inclusion Criteria:

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary melanoma.

   OR

   Subject has high suspicion of primary malignancy of melanoma based on skin exam or imaging.

3. 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:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
3. 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.
4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
5. Less than 5 days between biopsy (other than FNA) of target pathology and blood collection.
6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
7. 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.

Approximately 350 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated melanoma or a high suspicion of primary malignancy of melanoma.

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.

Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.