DCIS Clinical Trial - Molecular Analysis of the Sloane Project

Status Enrolling by invitation

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05868252
Study type	Observational
Source	King's College London
Contact
Status	Enrolling by invitation
Phase
Start date	March 1, 2020
Completion date	May 19, 2024

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT03535506` - Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery	Phase 2
Recruiting	`NCT04797299` - Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
Completed	`NCT02637024` - Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation	Phase 2
Completed	`NCT00148655` - Educational Interventions for Patients With DCIS	N/A
Suspended	`NCT03936478` - Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer	Phase 2
Recruiting	`NCT03878342` - Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast	N/A
Recruiting	`NCT03793829` - Neoadjuvant Multi-epitope HER2 Peptide Vaccine in Patients With HER2-expressing DCIS	Phase 1/Phase 2
Active, not recruiting	`NCT04245150` - Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
Recruiting	`NCT06388304` - THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence	N/A
Not yet recruiting	`NCT06217458` - The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS	N/A
Recruiting	`NCT04722692` - Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ	Phase 3
Recruiting	`NCT05912569` - Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS	N/A
Recruiting	`NCT04049214` - Perioperative Mindfulness Proposal	N/A
Completed	`NCT02061332` - DC Vaccine for Patients With Ductal Carcinoma In Situ	Phase 1/Phase 2
Recruiting	`NCT04916808` - The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
Withdrawn	`NCT05436808` - Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer	Early Phase 1
Recruiting	`NCT05900986` - LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer	Phase 1/Phase 2
Suspended	`NCT03448926` - The PREDICT Registry for DCIS Patients With DCISionRT Testing

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.