The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
- Conditions
- Newly-diagnosed CancersNon-cancer Controls
- Interventions
- Diagnostic Test: Freenome Test
- Registration Number
- NCT05516927
- Lead Sponsor
- Freenome Holdings Inc.
- Brief Summary
This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 788
- Age ≥30 years within 30 days of enrollment
- Able and willing to provide blood samples per protocol
- Able to comprehend and willing to sign and date the informed consent and HIPAA
- Authorization documents
- Able and willing to allow existing health data to be utilized for study purposes
Key
- Any history of solid organ or bone marrow transplantation
- Any physical trauma or surgery requiring inpatient overnight hospitalization in the 30 days preceding enrollment
- Received a blood transfusion in the 30 days preceding enrollment
- A medical condition that, in the opinion of the Investigator, should preclude enrollment in the study
- Known to be pregnant
- Any therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment
- Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 30 days preceding enrollment
- Participated or currently participating in another Freenome-sponsored clinical study
- For non-cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
- For the cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment, apart from the current cancer diagnosis; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-cancer Group Freenome Test * Collect Subject Data * Collect Blood Specimen Cancer Group Freenome Test * Collect Subject Data * Collect Blood Specimen
- Primary Outcome Measures
Name Time Method Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants 12 months To compare blood samples from cancer case and non-cancer control subjects in order to develop and characterize blood-based multiomics tests in specific cancer types or in a combination of multiple cancers.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
INOVA
🇺🇸Fairfax, Virginia, United States
Crisp Regional Hospital
🇺🇸Cordele, Georgia, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Silver Cross Hospital and Medical centers
🇺🇸Orland Park, Illinois, United States
Margaret Mary
🇺🇸Batesville, Indiana, United States
Carroll County Memorial Hospital
🇺🇸Carrollton, Missouri, United States
Hannibal Regional Hospital
🇺🇸Hannibal, Missouri, United States
MUSC
🇺🇸Charleston, South Carolina, United States
North Kansas City Hospital
🇺🇸North Kansas City, Missouri, United States
St Joseph University
🇺🇸Paterson, New Jersey, United States
Winona Health System
🇺🇸Winona, Minnesota, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
University Health Truman Medical Center
🇺🇸Kansas City, Missouri, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Geisinger Bloomsburg Hospital
🇺🇸Bloomsburg, Pennsylvania, United States
MacLeod Center for Cancer Treatment and Research
🇺🇸Florence, South Carolina, United States
Elligo Health Research, Inc.
🇺🇸Austin, Texas, United States
Allina Health Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Inspira Medical Center
🇺🇸Mullica Hill, New Jersey, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States