DCISNCT05868252
Molecular Analysis of the Sloane Project
An observational study of DCIS and LCIS, run by King's College London at 1 site in United Kingdom.
Trial summary
The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- DCIS, LCIS, Atypical Ductal Hyperplasia
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2020to 19 May 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Those who have undergone breast screening and were part of the Sloane Project audit
Who may be able to join
- DCIS (Ductal Carcinoma in situ)
- LCIS (Lobular Carcinoma in situ)
- Atypical hyperplasias
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Analysis of Screen Detected Non-invasive Breast Cancer and Atypical Breast Hyperplasias Identified by the Sloane Project
The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater).
The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer.
Read more
All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional ~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis.
The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.
- Conditions
- DCIS, LCIS, Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of breast disease
Measured: From diagnosis to end of 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Mar 2020
- Primary completion19 May 2024 (estimated)
- Study completion19 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DCISStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elinor Sawyer, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868252
- Sponsor's protocol ID
- 19/LO/0648
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Screen Detected Non-invasive Breast Cancer and Atypical Breast Hyperplasias Identified by the Sloane Project
- ClinicalTrials.gov ID
- NCT05868252
- Acronym / sponsor ID
- 19/LO/0648
- Conditions
- DCIS, LCIS, Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 19 May 2024 (estimated)
- Study completion
- 19 May 2024 (estimated)
- First posted
- 22 May 2023 (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.
The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater).
The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer.
All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional ~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis.
The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Those who have undergone breast screening and were part of the Sloane Project audit
Key inclusion criteria (3 listed)
- DCIS (Ductal Carcinoma in situ)
- LCIS (Lobular Carcinoma in situ)
- Atypical hyperplasias
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression of breast disease
Time frame: From diagnosis to end of 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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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.
Elinor Sawyer principal investigator
King's College London
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 DCIS and LCIS, run by King's College London 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 May 2023. 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?
Results are not available in the source record.
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?
Progression of breast disease (time frame: From diagnosis to end of 2016). 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 22 May 2023.