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RECRUITING
NCT04495244

A Study to Identify Breast Cancer (IDBC)

Sponsor: Syantra Inc.

View on ClinicalTrials.gov

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.

Official title: Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)

Key Details

Gender

FEMALE

Age Range

30 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2019-01-24

Completion Date

2032-12-31

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Syantra DX Breast Cancer

Blood test for detecting the presence of breast cancer.

Locations (4)

Alberta Cancer Research Biobank

Calgary, Alberta, Canada

Severance Hospital

Soeul, South Korea

North Manchester General Hospital

Manchester, United Kingdom

Wythenshawe Hospital, Southmoor Road

Manchester, United Kingdom