Clinical trial · Observational
Breast Screening Atypia and Subsequent Development of Cancer in England
Breast Screening Atypia and Subsequent Development of Cancer: an Observational Analysis of the Sloane Database in England (Sloane Atypia Cohort Study)
NCT05402436CI-TRIAL-00084774completedClinicalTrials.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)
During breast screening, atypical epithelial proliferations (atypia) can be detected. These are not cancer, but may mean that a woman is more likely to develop breast cancer in the future. This study explores how atypia develop into breast cancer in terms of number of women, time to cancer development, cancer type and severity, and whether this varies for different types of atypia. The results will be used to create new guidelines for how women with atypia should be followed up.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A diagnosis of atypia as part of the English screening programme | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women attending Breast Cancer Screening in England with an atypia diagnosis
- description
- Women attending Breast Cancer Screening in England with an atypia diagnosis between 1st January 2003 and 30th June 2018
- interventionNames
- Other: A diagnosis of atypia as part of the English screening programme
Primary outcomes (2)
- measure
- Invasive breast cancer at 3 years following atypia diagnosis
- timeFrame
- Cumulative incidence of invasive breast cancer with all cause mortality as a competing risk at 3 years following atypia diagnosis
- description
- Invasive breast cancer rate at 3 years following atypia diagnosis (representing the first round of screening) for all atypia, by type of atypia, by level of management off atypia, by three 5-year periods (deviding study period into 2003 to 2007, 2008 to 2012 and 2013 to 2018), by location (ipsilateral, contralateral), by age group, and by complete vs incomplete reporting of atypia cases by screening centres
- measure
- Invasive breast cancer at 6 years following atypia diagnosis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 47 Years
- Maximum age
- 73 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of epithelial atypia (ADH (including AIDEP), LISN (both ALH and LCIS) and FEA) in the Sloane database between 1st January 2003 and 30th June 2018 Exclusion Criteria: * bilateral primary cases * the "best prognosis" atypia of the bilateral primaries * atypia with co-existing DCIS * pleomorphic LCIS (as these are managed akin to DCIS) * unknown type of atypia * cases not from England * patients without follow-up until 31 December 2018
References
Publications (3)
- RESULTJenkinson D, Freeman K, Clements K, Hilton B, Dulson-Cox J, Kearins O, Stallard N, Wallis MG, Sharma N, Kirwan C, Pinder S, Provenzano E, Shaaban AM, Stobart H, McDonnell S, Thompson AM, Taylor-Phillips S. Breast screening atypia and subsequent development of cancer: protocol for an observational analysis of the Sloane database in England (Sloane atypia cohort study). BMJ Open. 2022 Jan 7;12(1):e058050. doi: 10.1136/bmjopen-2021-058050. PMID 34996804
- RESULTFreeman K, Mansbridge A, Stobart H, Clements K, Wallis MG, Pinder SE, Kearins O, Shaaban AM, Kirwan CC, Wilkinson LS, Webb S, O'Sullivan E, Jenkins J, Wright S, Taylor K, Bailey C, Holcombe C, Wyld L, Edwards K, Jenkinson DJ, Sharma N, Provenzano E, Hilton B, Stallard N, Thompson AM, Taylor-Phillips S. Evidence-informed recommendations on managing breast screening atypia: perspectives from an expert panel consensus meeting reviewing results from the Sloane atypia project. Br J Radiol. 2024 Feb 2;97(1154):324-330. doi: 10.1093/bjr/tqad053. PMID 38265306
- RESULTFreeman K, Jenkinson D, Clements K, Wallis MG, Pinder SE, Provenzano E, Stobart H, Stallard N, Kearins O, Sharma N, Shaaban A, Kirwan CC, Hilton B, Thompson AM, Taylor-Phillips S; Sloane Project Steering Group. Atypia detected during breast screening and subsequent development of cancer: observational analysis of the Sloane atypia prospective cohort in England. BMJ. 2024 Feb 1;384:e077039. doi: 10.1136/bmj-2023-077039. PMID 38302129