A Study to Identify Breast Cancer (IDBC)

Condition(s) studied

Investigational drug(s) / intervention(s)

Syantra DX Breast Cancer: Blood test for detecting the presence of breast cancer.

Study summary

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

Primary outcome measure(s)

• Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity — through completion of the study. Individual participant data for primary outcome recorded about 18 months from enrollment.
  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.

Trial sites (4)

More Syantra Inc. trials in the UK