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A Study to Identify Breast Cancer (IDBC)

Recruitingn/aAges 30 Years - 75 YearsFemaleSyantra Inc.
NCT04495244 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, pathol

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📋 Eligibility rules (as published)
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
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What it tests

  • Syantra DX Breast Cancer
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Where

4 sites
Alberta Cancer Research Biobank
Calgary, Canada
Severance Hospital
Soeul, South Korea
North Manchester General Hospital
Manchester, United Kingdom
Wythenshawe Hospital, Southmoor Road
Manchester, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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