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A Study to Identify Breast Cancer (IDBC)

NCT04495244 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2026-08-19

No results posted yet for this 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.

Conditions

  • Breast Cancer Female

Interventions

DIAGNOSTIC_TEST

Syantra DX Breast Cancer

Blood test for detecting the presence of breast cancer.

Sponsors & Collaborators

Principal Investigators

  • Nigel Bundred, MD · Manchester University NHS Foundation Trust

  • Cliona Kirwin, MD · Manchester University NHS Foundation Trust

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2032-12-31
Completion
2032-12-31

Countries

  • Canada
  • South Korea
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495244 on ClinicalTrials.gov