Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening to Improve Early Diagnosis for Women of All Social and Ethnic Backgrounds
Syantra Inc.
Summary
Breast cancer is the most common cancer that spreads beyond the initial layer of tissue it developed in, and grows into surrounding healthy tissue in women worldwide. It is associated with significant illness and death. Identifying the disease in the early stage is important to achieving positive outcomes in response to diagnosis and treatment. The Syantra blood test has been developed over the past 10 years. This test involves examining blood samples to identify and analyze specific information. This information is run through a software program that then potentially identifies the presence of breast cancer in the blood sample. This test has the potential to increase early stage detection of breast cancer. The main goal of this study is to figure out how well the Syantra blood test identifies the presence of breast cancer in women 30-75 years of age. The study will also look at whether things like ethnicity, geography and certain individual characteristics (including breast density and elevated risk of breast cancer development) have an effect on how well the test works. This study will recruit women who are attending a visit at the site who are aged 30-75 who are undergoing testing for the presence of breast cancer as part of their regular screening or planned follow up imaging and/or biopsy. Participants who provide consent and meet eligibility criteria will complete a baseline questionnaire and have their blood drawn before any scheduled procedures. Relevant information will be collected from their medical record at the time of joining the study and will be reviewed and updated within 60 days and then again at 12 months following the baseline blood draw. Participants will not have to do anything after the initial visit where they may sign consent, complete the intake questionnaire and have their blood drawn.
Description
Primary Objective: Determine clinical performance metrics of the Syantra blood test in a population of women 30-75 years of age. Secondary Objectives: Investigate the role of ethnicity, geography, and participant characteristics (including breast density and elevated risk of breast cancer development) on test performance. Investigate tumor characteristics and test development. Study Design: Non-randomized, blinded, non-interventional, longitudinal, multi-center Investigational Device: Syantra blood test Population: Women age 30-75 years testing for the presence of breast cancer as part of re…
Eligibility
- Age range
- 30–75 years
- Sex
- Female
- Healthy volunteers
- Yes
1. Elevated risk population sub-group: Women at elevated risk undergoing routine screening for breast cancer. A. Asymptomatic Screening Inclusion Criteria * Age ≥ 30 and ≤ 75 * Planned MRI (for women who qualify) and/or planned screening mammogram (and/or breast ultrasound) * Presentation of factor(s) indicating elevated risk for breast cancer development o Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime r…
Locations (4)
- Vincere Cancer CenterPhoenix, Arizona
- Weill Cornell Medicine of Cornell UniversityNew York, New York
- Alberta Cancer Research BiobankCalgary, Alberta
- Manchester University NHS Foundation TrustManchester