Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting

NCT06578988 | Unknown DMC

• 1 other identifier: CCR5910
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief Summary

Artificial Intelligence (AI) systems for the classification of mammography images have been developed and are beginning to be trialled and deployed in a breast cancer screening setting with encouraging results. It is reasonable to think that these systems could be useful in the context of symptomatic breast clinic. However, these systems developed in the screening setting have unknown performance in the context of symptomatic breast clinic. It is therefore important to test the performance of these systems in this alternative context. This study will use retrospective data, from where it is possible to determine ground truth outcomes with greater confidence, accessing relatively large volumes of data with less patient burden when compared to prospective studies. This important cohort of patients has been less investigated to date, mainly because symptomatic data is typically more difficult to curate than screening data where key data is methodically prospectively collected. The proposed work will be carried out in collaboration with a selected AI vendor and local clinical teams to define optimal use case scenarios for the symptomatic breast clinic.

Conditions

Cancer, Breast

Outcome Measures

Primary Outcomes (1)

• Performance of screening tool on symptomatic data, in terms of sensitivity and specificity.

  18 months

Secondary Outcomes (1)

• Subgroup analysis based on ground-truth - Normal; Benign; Malignant.

  18 months

Study Arms (1)

Symptomatic breast clinic.

Patients 18 years or older attending symptomatic breast clinic from January 2015 to December 2019.

Procedure: Mammography Images

Interventions

Mammography Images PROCEDURE

Ultrasound and / or mammography are typically performed and reported by the imaging team at the same visit, with biopsy performed when indicated. This service is an important part of cancer care provision, with approximately half of the breast cancers diagnosed presenting via the symptomatic service rather than identified at screening.

Symptomatic breast clinic.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient attending a symptomatic breast clinic at the recruiting sites

You may qualify if:

• Patients 18 years or older attending symptomatic breast clinic.
• Mammography images, including both full field two-dimensional digital mammography and digital breast tomosynthesis.
• Dates of attendance will be from January 2015\* to December 2019 at the lead data collection site. Dates of collection may be different at the other sites depending on local data curation consideration but will be a minimum of 2 years prior to study start to allow determination of ground truth.
• If any mammography images prior to 2015 should be available at the lead site, these will be collected as well (a maximum of 3). Prior mammograms will also be collected at the other sites if available, depending on local PACS set-up.

You may not qualify if:

• Patients under the age of 18 years.
• Patients on the National data opt out.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Imperial College Healthcare NHS Trust: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• Royal Surrey County Hospital NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: August 30, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)