Status:
UNKNOWN
A Study to Identify Breast Cancer (IDBC)
Lead Sponsor:
Syantra Inc.
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
30-75 years
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 identif...
Detailed Description
The current project is aimed at validating Syantra DX Breast Cancer in a UK population. Results of the UK study will be combined with those from additional sites, including those in Canada, with addit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 24 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04495244
Start Date
January 24 2019
End Date
December 31 2022
Last Update
July 31 2020
Active Locations (1)
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1
Wythenshawe Hospital, Southmoor Road
Manchester, United Kingdom, M23 9LT