Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
- Conditions
- Melanoma
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT03727087
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 348
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Melanoma Blood Sample Collection 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.
- Primary Outcome Measures
Name Time Method Blood-based biomarkers associated with genetic and epigenetic alterations. Point in time blood collection (1 day) at enrollment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
East Carolina University Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Franciscan Health Indianapolis
🇺🇸Indianapolis, Indiana, United States
Middlesex Hospital
🇺🇸Middletown, Connecticut, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
Palmtree Clinical Research, Inc
🇺🇸Palm Springs, California, United States
Balanced Life Health Care Solutions, LLC
🇺🇸Buford, Georgia, United States
PMG Research, INC
🇺🇸Downers Grove, Illinois, United States
Somnos Laboratories, Inc.
🇺🇸Lincoln, Nebraska, United States
IACT Health (DBA John B. Amos Cancer Center)
🇺🇸Columbus, Georgia, United States
HealthPartner Institute
🇺🇸Bloomington, Minnesota, United States
Mid-Florida Hematology and Oncology Center
🇺🇸Orange City, Florida, United States
DermAssociates, PC
🇺🇸Rockville, Maryland, United States
Wenatchee Valley Hospital
🇺🇸Wenatchee, Washington, United States
ProHealth Care
🇺🇸Oconomowoc, Wisconsin, United States
CARTI Cancer Center
🇺🇸Little Rock, Arkansas, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
HSHS St Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Dean Clinic - Fort Atkinson Specialty Services
🇺🇸Fort Atkinson, Wisconsin, United States
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Carle Cancer Center NCI
🇺🇸Urbana, Illinois, United States
MediSync Clinical Research
🇺🇸Pflugerville, Texas, United States
Aim Trials, LLC
🇺🇸Plano, Texas, United States
Austin Institute for Clinical Research
🇺🇸Pflugerville, Texas, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Cancer Alliance of Nebraska
🇺🇸Omaha, Nebraska, United States
San Fernando Valley Health Institute
🇺🇸Van Nuys, California, United States
St. Elizabeth Medical Center
🇺🇸Edgewood, Kentucky, United States
Cancer Research Consortium of West Michigan
🇺🇸Grand Rapids, Michigan, United States
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
Spartanburg Regional Healthcare District
🇺🇸Spartanburg, South Carolina, United States
The Jackson Clinic Professional Association
🇺🇸Jackson, Tennessee, United States