A Study to Identify Breast Cancer (IDBC)
Recruiting · NCT04495244 · Observational (researchers observe without assigning treatment) · Lead sponsor: Syantra Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Abnormal screening mammogram with suspected benign breast disease or proliferative changes
Exclusion criteria
- 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
- Concomitant or other concurrent anti-cancer therapy
- Inoperable or inflammatory breast cancer
Where it is running
4 locations listed.
- North Manchester General Hospital - Manchester, United Kingdom
- Wythenshawe Hospital, Southmoor Road - Manchester, United Kingdom
- Severance Hospital - Soeul, South Korea
- Alberta Cancer Research Biobank - Calgary, Alberta, Canada