Clinical trial NCT05516927: The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Official title: The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newly-diagnosed Cancers
Non-cancer Controls
Keywords: Liquid Biopsy
Blood Test
Cancer Diagnostic
Genomics
Multiomics
Artificial Intelligence
Screening
Machine Learning
Freenome
Early Detection
Multicancer
Lead sponsor: Freenome Holdings Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 788
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Adults 30+ who have been newly diagnosed with cancer and treatment-naive
* Adults 30+ without cancer

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.


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

Primary outcomes:
measure: Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cordele
country: United States
facility: Crisp Regional Hospital
state: Georgia
city: Orland Park
country: United States
facility: Silver Cross Hospital and Medical centers
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Batesville
country: United States
facility: Margaret Mary
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute
state: Minnesota
city: Winona
country: United States
facility: Winona Health System
state: Minnesota
city: Carrollton
country: United States
facility: Carroll County Memorial Hospital
state: Missouri
city: Hannibal
country: United States
facility: Hannibal Regional Hospital
state: Missouri
city: Kansas City
country: United States
facility: University Health Truman Medical Center
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Mullica Hill
country: United States
facility: Inspira Medical Center
state: New Jersey
city: Paterson
country: United States
facility: St Joseph University
state: New Jersey
city: Statesville
country: United States
facility: Iredell Memorial Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bloomsburg
country: United States
facility: Geisinger Bloomsburg Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Florence
country: United States
facility: MacLeod Center for Cancer Treatment and Research
state: South Carolina
city: Austin
country: United States
facility: Elligo Health Research, Inc.
state: Texas
city: Fairfax
country: United States
facility: INOVA
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
References: