Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies

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: Hematologic Malignancy
• Intervention / Treatment: Other: Blood Sample Collection

Detailed Description

Subjects will have been recently diagnosed with an untreated hematologic malignancy. 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): 409

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72903
      • Mercy Fort Smith
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • California
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Oceanside, California, United States, 92056
      • North County Oncology
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Middlesex Hospital
    • Stamford, Connecticut, United States, 06904
      • The Stamford Hospital
  • Florida
    • Orange City, Florida, United States, 32765
      • Mid-Florida Hematology and Oncology Center
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • PMG Research, Inc
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare-Peoria
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research, Inc.
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center NCI
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood and Marrow Transportation
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Medical Center
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Louisville, Kentucky, United States, 40207
      • Baptist Health Louisville
    • Paducah, Kentucky, United States, 42003
      • Baptist Health Paducah
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • RCCA MD Inc.
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Cancer Research Consortium of West Michigan
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartner Institute
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Mercy Joplin
    • Saint Louis, Missouri, United States, 63141
      • Mercy St. Louis
    • Springfield, Missouri, United States, 65804
      • Mercy Springfield
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University Brody School of Medicine
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Outpatient Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Oklahoma City
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Bon Secours St Francis Cancer Center
    • Spartanburg, South Carolina, United States, 29301
      • Spartanburg Regional Healthcare District
    • West Columbia, South Carolina, United States, 29169
      • Lexington Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
  • Utah
    • Ogden, Utah, United States, 84405
      • Community Cancer Trials of Utah
  • Washington
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Clinical Trials Center
  • Wisconsin
    • Fort Atkinson, Wisconsin, United States, 53538
      • Dean Clinic - Fort Atkinson Specialty Services
    • 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 500 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated hematologic malignancy.

Description

Inclusion Criteria:

• Subject is male or female ≥ 18 years of age.
• Subject has an untreated hematologic malignancy.
• 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:

• 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. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment prior to blood sample collection.
• Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
• Less than 7 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hematologic Malignancy; Subjects with clinically confirmed hematologic malignancy and who are treatment naive will provide a blood sample at the 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 a hematologic malignancy 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): December 7, 2018
• 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 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: blood draw; sample collections
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 2018-02

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; Informed Consent Form (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