Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies
- Conditions
- Hematologic Malignancy
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT03727009
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 409
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hematologic Malignancy Blood Sample Collection 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.
- 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 a hematologic malignancy at the pre-intervention stage.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Spartanburg Regional Healthcare District
🇺🇸Spartanburg, South Carolina, United States
Mercy Fort Smith
🇺🇸Fort Smith, Arkansas, United States
Marin Cancer Care
🇺🇸Greenbrae, California, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
North County Oncology
🇺🇸Oceanside, California, United States
Mid-Florida Hematology and Oncology Center
🇺🇸Orange City, Florida, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
PMG Research, INC
🇺🇸Downers Grove, Illinois, United States
Orchard Healthcare Research, Inc.
🇺🇸Skokie, Illinois, United States
Carle Cancer Center NCI
🇺🇸Urbana, Illinois, United States
St. Elizabeth Medical Center
🇺🇸Edgewood, Kentucky, United States
Indiana Blood and Marrow Transportation
🇺🇸Indianapolis, Indiana, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Baptist Health Louisville
🇺🇸Louisville, Kentucky, United States
Baptist Health Paducah
🇺🇸Paducah, Kentucky, United States
RCCA MD Inc.
🇺🇸Bethesda, Maryland, United States
HealthPartner Institute
🇺🇸Bloomington, Minnesota, United States
Mercy Joplin
🇺🇸Joplin, Missouri, United States
Mercy St. Louis
🇺🇸Saint Louis, Missouri, United States
Mercy Springfield
🇺🇸Springfield, Missouri, United States
East Carolina University Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
FirstHealth Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Mercy Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Bon Secours St Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
Community Cancer Trials of Utah
🇺🇸Ogden, Utah, United States
Wenatchee Valley Hospital
🇺🇸Wenatchee, Washington, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Dean Clinic - Fort Atkinson Specialty Services
🇺🇸Fort Atkinson, Wisconsin, United States
ProHealth Care
🇺🇸Oconomowoc, Wisconsin, United States
Middlesex Hospital
🇺🇸Middletown, Connecticut, United States
Cancer Research Consortium of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CARTI Cancer Center
🇺🇸Little Rock, Arkansas, United States