The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

Freenome

Status

Completed

Conditions

Non-cancer Controls

Newly-diagnosed Cancers

Treatments

Diagnostic Test: Freenome Test

Study type

Observational

Funder types

Industry

Identifiers

NCT05516927

The Sanderson Study/FRNM-006

Details and patient eligibility

About

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.

Enrollment

788 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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