Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

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.

Study Overview

• Status: Terminated
• Conditions: Melanoma
• Intervention / Treatment: Other: Blood Sample Collection

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.

• Study Type: Observational
• Enrollment (Actual): 348

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Carti Cancer Center
  • California
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research, INC
    • Van Nuys, California, United States, 91405
      • San Fernando Valley Health Institute
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Middlesex Hospital
    • Stamford, Connecticut, United States, 06904
      • The Stamford Hospital
  • Florida
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research, LLC
    • Orange City, Florida, United States, 32765
      • Mid-Florida Hematology and Oncology Center
    • Tampa, Florida, United States, 33609
      • Olympian Clinical Research
  • Georgia
    • Buford, Georgia, United States, 30518
      • Balanced Life Health Care Solutions, LLC
    • Columbus, Georgia, United States, 31904
      • IACT Health (DBA John B. Amos Cancer Center)
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • PMG Research, Inc
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center NCI
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health Indianapolis
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Medical Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates, PC
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Cancer Research Consortium of West Michigan
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartner Institute
  • Mississippi
    • Petal, Mississippi, United States, 39465
      • MediSync Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Somnos Laboratories, Inc.
    • Omaha, Nebraska, United States, 68106
      • Cancer Alliance of Nebraska
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University Brody School of Medicine
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount, LLC
  • Ohio
    • Dayton, Ohio, United States, 45419
      • MediSync Clinical Research
  • South Carolina
    • Spartanburg, South Carolina, United States, 29301
      • Spartanburg Regional Healthcare District
    • West Columbia, South Carolina, United States, 29169
      • Lexington Medical Center
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic Professional Association
  • Texas
    • Austin, Texas, United States, 78726
      • MediSync Clinical Research
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research
    • Pflugerville, Texas, United States, 78660
      • MediSync Clinical Research
    • Plano, Texas, United States, 75093
      • AIM Trials, LLC
  • Washington
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital
  • Wisconsin
    • Fort Atkinson, Wisconsin, United States, 53538
      • Dean Clinic - Fort Atkinson Specialty Services
    • Green Bay, Wisconsin, United States, 54301
      • HSHS St Vincent Hospital Regional Cancer Center
    • Oconomowoc, Wisconsin, United States, 53066
      • ProHealth Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ACTUAL): March 24, 2020
• Study Completion (ACTUAL): March 24, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (ACTUAL): November 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 2018-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No