Breast Cancer Clinical Trial
— POSTBOxOfficial title:
Patient Outcomes From Second Film-readers and Test Threshold Relaxation in Breast Screening: An Observational Retrospective Cohort Study
Verified date | May 2023 |
Source | University of Warwick |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Analysis of women's medical records to understand the impact of previous changes to breast cancer screening (increase from one to two clinicians examining each woman's mammograms, and what proportion of women they recall for further tests)
Status | Enrolling by invitation |
Enrollment | 10000000 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 47 Years to 73 Years |
Eligibility | Inclusion Criteria: - Women who attended the English National Health Service (NHS) breast cancer screening service at least once between 1988 and 2016, aged between 47 and 73 - All eligible episodes of screening for each woman (we expect women to be screened around 7 times each) Exclusion Criteria: - Women who did not attend routine English NHS Breast screening service within the specified date and age range, even if they attended symptomatic breast cancer services, high risk (family history) breast screening services, or if they were referred for mammograms by their general practitioner |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Univesity of Warwick | Coventry | Warwickshire |
Lead Sponsor | Collaborator |
---|---|
University of Warwick | Public Health England |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method | Overdiagnosis of breast cancer (measured as difference in total cancer incidence, screen and symptomatic). Will also report mechanism of action (number of screen detected cancers, number of symptomatically detected cancers at 3,13, and 30 years follow-up) | 13 years, and up to 30 years | |
Primary | Cancers detected at screening | Biopsy proven cancers detected at screening | 1 day screening episode | |
Primary | False positive recalls | Recall of women for further tests after screening which did not result in detection of cancer | 1 day screening episode | |
Primary | Breast cancer mortality | Mortality due to breast cancer (dependent on securing follow-on funding) | 13 years, and up to 30 years | |
Primary | All cause mortality | Mortality due to any cause (dependent on securing follow on funding) | 13 years, and up to 30 years | |
Primary | Characteristics of cancer detected | Size, grade and stage (reported overall, screen detected, and symptomatic detected). | 1 day screening episode, 3year, 13 year and up to 30 year follow up | |
Secondary | Breast cancer morbidity | Treatment received as a proxy for treatment associated morbidity (reported overall, screen detected and symptomatically detected, if follow on funding obtained) | Up to 30 years | |
Secondary | Breast cancer free survival | Survival without a diagnosis of breast cancer | Up to 30 years follow-up |
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