Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

Stopped early

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT03727087

Run by

Exact Sciences Corporation

People needed

348

Starts

2019-01-10

Expected to finish

2020-03-24

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CARTI Cancer Center — Little Rock, Arkansas, United States
• Alliance Research Centers — Laguna Hills, California, United States
• Palmtree Clinical Research, Inc — Palm Springs, California, United States
• San Fernando Valley Health Institute — Van Nuys, California, United States
• Middlesex Hospital — Middletown, Connecticut, United States
• The Stamford Hospital — Stamford, Connecticut, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• Mid-Florida Hematology and Oncology Center — Orange City, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Balanced Life Health Care Solutions, LLC — Buford, Georgia, United States
• IACT Health (DBA John B. Amos Cancer Center) — Columbus, Georgia, United States
• PMG Research, INC — Downers Grove, Illinois, United States
• Carle Cancer Center NCI — Urbana, Illinois, United States
• Franciscan Health Indianapolis — Indianapolis, Indiana, United States
• St. Elizabeth Medical Center — Edgewood, Kentucky, United States
• DermAssociates, PC — Rockville, Maryland, United States
• Cancer Research Consortium of West Michigan — Grand Rapids, Michigan, United States
• HealthPartner Institute — Bloomington, Minnesota, United States
• MediSync Clinical Research — Petal, Mississippi, United States
• Somnos Laboratories, Inc. — Lincoln, Nebraska, United States
• Cancer Alliance of Nebraska — Omaha, Nebraska, United States
• East Carolina University Brody School of Medicine — Greenville, North Carolina, United States
• PMG Research of Rocky Mount, LLC — Rocky Mount, North Carolina, United States
• MediSync Clinical Research — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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