The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting
Trial ID: NCT05516927
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-09-06
Completion date: 2024-05-02
Sponsor: Freenome Holdings Inc.
Conditions: Newly-diagnosed Cancers; Non-cancer Controls
Interventions: Freenome Test
Locations: Crisp Regional Hospital; Silver Cross Hospital and Medical centers; Advocate Lutheran General Hospital; Margaret Mary; Henry Ford Health; Allina Health Cancer Institute; Winona Health System; Carroll County Memorial Hospital; Hannibal Regional Hospital; University Health Truman Medical Center; North Kansas City Hospital; Renown Regional Medical Center; Inspira Medical Center; St Joseph University; Iredell Memorial Hospital; Cleveland Clinic; Oregon Health and Science University; Geisinger Bloomsburg Hospital; MUSC; MacLeod Center for Cancer Treatment and Research; Elligo Health Research, Inc.; INOVA; Aurora St. Luke's Medical Center
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 788
Age range: 30 Years - None
Sex: ALL

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.

Eligibility criteria:
Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Outcomes:
Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants