Study Stopped
COVID-19
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
1 other identifier
observational
348
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedStudy Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2020
CompletedFebruary 10, 2021
February 1, 2021
1.2 years
October 23, 2018
February 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Melanoma
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.
Interventions
Subjects participating in the study will have blood drawn at enrollment.
Eligibility Criteria
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.
You may qualify if:
- Subject is male or female \> 18 years of age.
- Subject has an untreated primary melanoma.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Palmtree Clinical Research, Inc
Palm Springs, California, 92262, United States
San Fernando Valley Health Institute
Van Nuys, California, 91405, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
The Stamford Hospital
Stamford, Connecticut, 06904, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204, United States
Mid-Florida Hematology and Oncology Center
Orange City, Florida, 32765, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Balanced Life Health Care Solutions, LLC
Buford, Georgia, 30518, United States
IACT Health (DBA John B. Amos Cancer Center)
Columbus, Georgia, 31904, United States
PMG Research, INC
Downers Grove, Illinois, 60515, United States
Carle Cancer Center NCI
Urbana, Illinois, 61801, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
DermAssociates, PC
Rockville, Maryland, 20850, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503, United States
HealthPartner Institute
Bloomington, Minnesota, 55425, United States
MediSync Clinical Research
Petal, Mississippi, 39465, United States
Somnos Laboratories, Inc.
Lincoln, Nebraska, 68510, United States
Cancer Alliance of Nebraska
Omaha, Nebraska, 68106, United States
East Carolina University Brody School of Medicine
Greenville, North Carolina, 27834, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
MediSync Clinical Research
Dayton, Ohio, 45419, United States
Spartanburg Regional Healthcare District
Spartanburg, South Carolina, 29301, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
The Jackson Clinic Professional Association
Jackson, Tennessee, 38305, United States
MediSync Clinical Research
Austin, Texas, 78726, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
MediSync Clinical Research
Pflugerville, Texas, 78660, United States
Aim Trials, LLC
Plano, Texas, 75093, United States
Wenatchee Valley Hospital
Wenatchee, Washington, 98801, United States
Dean Clinic - Fort Atkinson Specialty Services
Fort Atkinson, Wisconsin, 53538, United States
HSHS St Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301, United States
ProHealth Care
Oconomowoc, Wisconsin, 53066, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2018
First Posted
November 1, 2018
Study Start
January 10, 2019
Primary Completion
March 24, 2020
Study Completion
March 24, 2020
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 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.
- Access Criteria
- 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.
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.