A Study to Identify Breast Cancer (IDBC)
ConditionBreast Cancer Female
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-75
SponsorSyantra Inc.
About this trial
Detecting cancer as early as possible is key to achieving positive outcomes in response to diagnosis and treatment. The current project is aimed at validating a novel blood-based breast cancer identification test (Syantra DX Breast Cancer) that has been developed by Syantra Inc. Syantra DX Breast Cancer measures gene expression signatures in whole blood, and has been retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to analyse gene expression characteristics from a novel multi-biomarker panel, and then classify a sample as positive or negative for breast cancer. Based upon test performance in a retrospective environment, a prospective validation study is being proposed.
The primary objective of this study is to validate Syantra DX Breast Cancer methodology and biomarker panel using prospective samples, well categorized by diagnostic imaging scores, pathology outcomes, and subject characteristics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 30-75 years
Normal breast examination - No cancer detected/suspected by physical exam, diagnostic radiology or screening mammography
Women with suspected Invasive Breast Cancer
Individuals with an abnormal or suspicious mammogram
Disqualifiers
Cancer diagnosis
Male
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)
Previous history of any cancer
Trial population
Populations will be selected from women visiting the actively recruiting sites for breast cancer screening.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Syantra DX Breast Cancer
Diagnostic testBlood test for detecting the presence of breast cancer.
Treatment groups
10,000 Participants
are divided into 3 treatment groupsGroup A: Investigational Population1 intervention
Group B: Borderline (Atypica and LCIS) Population1 intervention
Group C: Control Population1 intervention
Trial outcomes
Primary outcomes
1
Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity
The number of participants that test positive or negative for breast cancer with the Syantra DX Breast Cancer test and their breast cancer status as assessed by mammography or pathology.
Time frame
through completion of the study. Individual participant data for primary outcome recorded about 18 months from enrollment.Secondary outcomes
1
Modulate test methodology to account for differences between retrospective and prospective samples
Determine the sensitivity and specificity of the assay with biomarker panel modifications.
Time frame
through completion of the study, approximately eighteen months2
Performance of the Syantra DX Breast Cancer test in prediction of molecular subtype of breast cancer as assessed by pathology
Correlate the performance of the test to molecular characterizations of identified cancers as assessed by pathology of tissue from biopsy or resection.
Time frame
through completion of the study, approximately eighteen monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Syantra Inc.
Lead sponsor
University of Calgary
Collaborator
Source ClinicalTrials.gov