Breast Cancer Female Clinical Trial
Official title:
Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)
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.
The current project is aimed at validating Syantra DX Breast Cancer in a UK population.
Results of the UK study will be combined with those from additional sites, including those in
Canada, with additional samples expected from the United States and South Korea. 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, and is described
below.
The study seeks to evaluate performance of Syantra DX Breast Cancer in prospective samples
and to optimize test methodology and biomarkers. Key to performance of the study is
recruitment of women who have received an abnormal mammography report, and have been
classified under the UK Royal College of Radiologists Breast Group (RCRBG) scoring system in
categories 3 - 5. This will support the ability to employ the test for breast cancer
detection in a screening/call-back environment. To complete the study cohort, additional
women will be recruited from the population who have normal or benign mammography results
(RCRBG category 1 and 2), and/or a recent normal physical breast exam, with no history of
breast cancer. Blood samples will be acquired from all women following completion of an
informed consent procedure.
For those with an abnormal mammogram, blood will be drawn before a biopsy is performed. All
sample information will be de-identified, and the samples will be processed and analysed
according to Syantra DX Breast Cancer standard operating procedures. These procedures include
extracting sample RNA and aliquoting for storage in a manner that maintains sample anonymity.
All processing and analysis will be conducted in a blind environment without knowing the
associated RCRBG or pathology outcomes for any samples. Only after testing is complete will
sample classifications be revealed. Syantra DX Breast Cancer results will then be compared to
RCRBG, biopsy and pathology data to determine concordance, and statistics will be calculated.
If or when biomarker panel or test methodology is modified during the performance of the
study, samples will be reanalysed with updated test parameters. This reanalysis will make use
of a de-identified aliquot of sample RNA to ensure that testing is maintained in a blind
environment.
There is an optional part of the study procedure that is included as 'additional research'. A
specific question seeking approval for the additional research is included on the study
consent form. For individuals who agree to participate in the additional research, material
extracted from their blood sample will be stored for additional investigations.
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