Study Stopped
COVID-19
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies
1 other identifier
observational
409
1 country
35
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 Dec 2018
35 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
December 7, 2018
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 3, 2021
February 1, 2021
1.3 years
October 23, 2018
February 2, 2021
Conditions
Keywords
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 a hematologic malignancy at the pre-intervention stage.
Point in time blood collection (1 day) at enrollment
Study Arms (1)
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.
Interventions
Subjects participating in the study will have blood drawn at enrollment.
Eligibility Criteria
Approximately 500 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated hematologic malignancy.
You may qualify if:
- 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.
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. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Mercy Fort Smith
Fort Smith, Arkansas, 72903, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Marin Cancer Care
Greenbrae, California, 94904, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
North County Oncology
Oceanside, California, 92056, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
The Stamford Hospital
Stamford, Connecticut, 06904, United States
Mid-Florida Hematology and Oncology Center
Orange City, Florida, 32765, United States
PMG Research, INC
Downers Grove, Illinois, 60515, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Orchard Healthcare Research, Inc.
Skokie, Illinois, 60077, United States
Carle Cancer Center NCI
Urbana, Illinois, 61801, United States
Indiana Blood and Marrow Transportation
Indianapolis, Indiana, 46237, United States
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Baptist Health Louisville
Louisville, Kentucky, 40207, United States
Baptist Health Paducah
Paducah, Kentucky, 42003, United States
RCCA MD Inc.
Bethesda, Maryland, 20817, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503, United States
HealthPartner Institute
Bloomington, Minnesota, 55425, United States
Mercy Joplin
Joplin, Missouri, 64804, United States
Mercy Springfield
Springfield, Missouri, 65804, United States
Mercy St. Louis
St Louis, Missouri, 63141, United States
East Carolina University Brody School of Medicine
Greenville, North Carolina, 27834, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Mercy Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Bon Secours St Francis Cancer Center
Greenville, South Carolina, 29607, United States
Spartanburg Regional Healthcare District
Spartanburg, South Carolina, 29301, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
Wenatchee Valley Hospital
Wenatchee, Washington, 98801, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Dean Clinic - Fort Atkinson Specialty Services
Fort Atkinson, Wisconsin, 53538, 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
December 7, 2018
Primary Completion
March 24, 2020
Study Completion
March 24, 2020
Last Updated
February 3, 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.