Clinical trial · Observational
Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening
Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening: an Observational Retrospective Cohort Study
NCT04365114CI-TRIAL-00085077POSTBOxcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Screening Mammography with single reader | Diagnostic Test | — | UNRESOLVED |
| Breast screening mammography with two readers | Diagnostic Test | — | UNRESOLVED |
| Test threshold | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Single reading
- description
- Only one clinician examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not.
- interventionNames
- Diagnostic Test: Breast Screening Mammography with single reader
- Diagnostic Test: Test threshold
- label
- Double reading
- description
- Two clinicians examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not.
- interventionNames
- Diagnostic Test: Breast screening mammography with two readers
- Diagnostic Test: Test threshold
Primary outcomes (6)
- measure
- Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 47 Years
- Maximum age
- 73 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.