Identify Breast Cancer (IDBC)
Research type
Research Study
Full title
Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)
IRAS ID
241391
Contact name
Nigel Bundred
Contact email
Sponsor organisation
Syantra Inc.
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Syantra Inc. has developed a test that is believed to enable detection of breast cancer from a blood sample. Research has been conducted over the last five years using both breast cancer cells and human blood samples to create the test, and results have shown good performance. To date, 780 patient samples have been investigated in a retrospective environment, leading to the need for additional data to validate the test. Material in the blood appears to contain information associated with the presence of breast cancer and may offer a way to identify individuals who can benefit from detailed breast imaging or a breast tissue biopsy.
The primary objective of this study is to validate the methodology and biomarkers of SyDetect™ Breast using prospective samples, well categorized by mammography scores, pathology outcomes, and subject characteristics.
Secondary objectives include:
1. Modulation of test methodology or biomarkers to account for differences in previously measured retrospective samples and newly obtained prospective samples that may be based upon study group characteristics, for example, ethnic or geographical differences.
2. Validation of test methodology and biomarkers to allow determination of basic tumour subtype in subjects with a positive test result.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0357
Date of REC Opinion
25 Jun 2018
REC opinion
Favourable Opinion