NCT04495244 A Study to Identify Breast Cancer (IDBC)
| NCT ID | NCT04495244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Syantra Inc. |
| Condition | Breast Cancer Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2019-01-24 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2019-01-24 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Nigel Bundred, MD
PRINCIPAL INVESTIGATOR
Manchester University NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04495244 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 75 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04495244 currently recruiting?
Yes, NCT04495244 is actively recruiting participants. Contact the research team at Natasha.Jones@mft.nhs.uk for enrollment information.
Where is the NCT04495244 trial being conducted?
This trial is being conducted at Calgary, Canada, Soeul, South Korea, Manchester, United Kingdom, Manchester, United Kingdom.
Who is sponsoring the NCT04495244 clinical trial?
NCT04495244 is sponsored by Syantra Inc.. The principal investigator is Nigel Bundred, MD at Manchester University NHS Foundation Trust. The trial plans to enroll 10,000 participants.
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