Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:January 10, 2019
End Date:February 14, 2020
Contact:Alexandra Massoud
Email:amassoud@exactsciences.com
Phone:608-957-5652

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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.

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.

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.
We found this trial at
7
sites
Laguna Hills, California 92653
Principal Investigator: Kenneth Deck
Phone: 949-680-3490
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Edgewood, Kentucky 41017
Principal Investigator: Brooke Phillips
Phone: 859-301-4726
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Edgewood, KY
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Lincoln, Nebraska 68510
Principal Investigator: Rodney Basler
Phone: 402-486-3430
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Lincoln, NE
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8901 Carti Way
Little Rock, Arkansas 72205
Principal Investigator: Kamal Patel
Phone: 501-906-3012
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Little Rock, AR
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2776 Enterprise Rd # 100
Orange City, Florida 32763
Principal Investigator: Santosh Nair
Phone: 407-353-1915
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Orange City, FL
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Stamford, Connecticut 06904
Principal Investigator: Salvatore Del Prete
Phone: 203-276-8449
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Stamford, CT
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Wenatchee, Washington 98801
Principal Investigator: Morrisa Baskin
Phone: 509-665-5800
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Wenatchee, WA
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