Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies
- Conditions
- Hematologic Malignancy
- 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
- 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)
Mercy Fort Smith
🇺🇸Fort Smith, Arkansas, United States
CARTI Cancer Center
🇺🇸Little Rock, 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
Middlesex Hospital
🇺🇸Middletown, Connecticut, United States
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Mid-Florida Hematology and Oncology Center
🇺🇸Orange City, Florida, United States
PMG Research, INC
🇺🇸Downers Grove, Illinois, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Scroll for more (25 remaining)Mercy Fort Smith🇺🇸Fort Smith, Arkansas, United States