Breast CancerPOSTBOxNCT04365114
Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening
An observational study of Breast Cancer and Ductal Carcinoma in Situ, run by University of Warwick at 1 site in United Kingdom.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 47 to 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma in Situ
- What is being tested?
- Breast Screening Mammography with single reader, Breast screening mammography with two readers and Test threshold
- How many people
- 13,094,122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who attended the English NHS Breast screening programme between 1988 and 2016 aged between 47 and 73.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Univesity of Warwick
Coventry, Warwickshire, CV47AL
About this study
Official title: Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening: an Observational Retrospective Cohort Study
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)
Read the detailed description
Retrospective observational study examining the records and outcomes of women who attended breast cancer screening between 1988 and 2016. Linkage of records from the breast screening service, the cancer registry, and mortality. Analysis of whether changing the threshold for whether to recall women for further tests or the number of clinicians examining the mammograms for signs of cancer affects outcomes.
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Being tested
- Breast Screening Mammography with single reader, Breast screening mammography with two readers, Test threshold
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Screening Mammography with single readerDiagnostic test
One clinician examined each woman's mammograms for signs of cancer
Breast screening mammography with two readersDiagnostic test
Two clinicians seperately examined each woman's mammograms for signs of cancer
Test thresholdDiagnostic test
Threshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled
| Study group | Role | What they receive |
|---|---|---|
| Single reading | Only one clinician examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not. Receives: Diagnostic Test: Breast Screening Mammography with single reader; Diagnostic Test: Test threshold | |
| Double reading | Two clinicians examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not. Receives: Diagnostic Test: Breast screening mammography with two readers; Diagnostic Test: Test threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 13 years, and up to 30 years
Cancers detected at screening
Biopsy proven cancers detected at screening
Measured: 1 day screening episode
False positive recalls
Recall of women for further tests after screening which did not result in detection of cancer
Measured: 1 day screening episode
Breast cancer mortality
Mortality due to breast cancer (dependent on securing follow-on funding)
Measured: 13 years, and up to 30 years
All cause mortality
Mortality due to any cause (dependent on securing follow on funding)
Measured: 13 years, and up to 30 years
Characteristics of cancer detected
Size, grade and stage (reported overall, screen detected, and symptomatic detected).
Measured: 1 day screening episode, 3year, 13 year and up to 30 year follow up
Secondary outcomes (2)
Breast cancer morbidity
Treatment received as a proxy for treatment associated morbidity (reported overall, screen detected and symptomatically detected, if follow on funding obtained)
Measured: Up to 30 years
Breast cancer free survival
Survival without a diagnosis of breast cancer
Measured: Up to 30 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Oct 2018
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,094,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Principal investigator, Sian Taylor-Phillips, University of Warwick
- Investigators
- Sian Taylor-Phillips, PhD, Principal investigator, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365114
- Sponsor's protocol ID
- 50619
- Acronym
- POSTBOx
- Status last verified
- Jan 2025
- First submitted
- 24 Apr 2020
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have Office of Data Release permissions to share these data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening: an Observational Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04365114
- Acronym / sponsor ID
- POSTBOx / 50619
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,094,122 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Retrospective observational study examining the records and outcomes of women who attended breast cancer screening between 1988 and 2016. Linkage of records from the breast screening service, the cancer registry, and mortality. Analysis of whether changing the threshold for whether to recall women for further tests or the number of clinicians examining the mammograms for signs of cancer affects outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single reading | – | Diagnostic Test: Breast Screening Mammography with single reader, Diagnostic Test: Test thresholdOnly one clinician examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not. |
| Double reading | – | Diagnostic Test: Breast screening mammography with two readers, Diagnostic Test: Test thresholdTwo clinicians examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not. |
Who may qualify
- Ages
- 47 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who attended the English NHS Breast screening programme between 1988 and 2016 aged between 47 and 73.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Screening Mammography with single readerOne clinician examined each woman's mammograms for signs of cancer | Diagnostic test | Single reading |
| Breast screening mammography with two readersTwo clinicians seperately examined each woman's mammograms for signs of cancer | Diagnostic test | Double reading |
| Test thresholdThreshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled | Diagnostic test | Double reading, Single reading |
Primary outcome
Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method
Time frame: 13 years, and up to 30 years
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)
Cancers detected at screening
Time frame: 1 day screening episode
Biopsy proven cancers detected at screening
False positive recalls
Time frame: 1 day screening episode
Recall of women for further tests after screening which did not result in detection of cancer
Breast cancer mortality
Time frame: 13 years, and up to 30 years
Mortality due to breast cancer (dependent on securing follow-on funding)
All cause mortality
Time frame: 13 years, and up to 30 years
Mortality due to any cause (dependent on securing follow on funding)
Characteristics of cancer detected
Time frame: 1 day screening episode, 3year, 13 year and up to 30 year follow up
Size, grade and stage (reported overall, screen detected, and symptomatic detected).
2 secondary outcomes
Breast cancer morbidity
Time frame: Up to 30 years
Breast cancer free survival
Time frame: Up to 30 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not have Office of Data Release permissions to share these data with other researchers
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sian Taylor-Phillips, PhD principal investigator
University of Warwick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Ductal Carcinoma in Situ, run by University of Warwick at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method (time frame: 13 years, and up to 30 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.