Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening

ConditionBreast Cancer, Liquid Biopsy, Early Detection

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age30-75

SponsorSyantra Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Elevated risk population sub-group: Women at elevated risk undergoing routine screening for breast cancer.

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

Willing and able to give Written Informed Consent and provide a whole blood sample

Disqualifiers

Physical breast symptoms or concerns

Current or suspected cancer diagnosis

Prior BI-RADS 3 or higher imaging results in last 12 months

Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months

Trial population

Screening and Recall population. Women in the Screening Cohort would be consented just prior to a screening imaging session (within 3 months). Recruitment may also occur after a normal screening imaging session (within 3 months). Women in the Recall population include women called back for follow-up after abnormal imaging or clinical exam. Women at elevated risk of breast cancer development are included. The primary target population for recruitment is women at elevated risk (C or D breast density, family history, and/or genetic elevated risk) called back (recalled) for follow-up imaging or biopsy after an abnormal image with the following distribution: 60% White (non-hispanic), 14% Black, 18% Hispanic, 6% Asian and 2% other.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants

are grouped into 4 trial groups

Group A: Elevated risk population - Asymptomatic

Group B: Elevated risk population -Recall

Group C: Recall (Secondary care) Symptomatic population

Group D: Asymptomatic average, low or unknown risk population

Trial outcomes

Primary outcomes

Sensitivity

Sensitivity (Se) if the test = TP/TP+FN), ratio of true positives to true positives and false negatives

Time frame

3 years

Specificity

Specificity (Sp) of the test = TN/ (TN+FP), ratio of true negatives to the true negatives and false positives

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Syantra Inc.

Lead sponsor

University of Calgary

Collaborator

Source ClinicalTrials.gov

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