A Prospective Multicenter Randomized Trial Comparing the Human-AI Collaborative INSIGHT Workflow vs. Conventional Pathology Diagnosis for Detecting Invasive Carcinoma in Breast Cancer With Extensive Intraductal Component (EIC)
Trial ID: NCT07060599
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-08-01
Completion date: 2027-08-01
Sponsor: Sun Yat-sen University
Conditions: Artificial Intelligence (AI) in Diagnosis
Interventions: INvasion Screening with Intelligent Guidance for Histopathology Triage (INSIGHT) Workflow
Locations: Sun Yat-sen University Cancer Center
Countries: China
Enrollment: 480
Age range: None - None
Sex: FEMALE

Summary:
The goal of this clinical trial is to see if an artificial intelligence (AI)-assisted method helps doctors more accurately detect invasive breast cancer in people with a specific type of tumor called "extensive intraductal carcinoma" (EIC). This type of tumor is challenging to diagnose correctly using standard methods. The main question this study aims to answer is: Does the new AI-assisted method find more invasive breast cancer in EIC tumors compared to the standard method?

Researchers will compare two groups:

* Group 1 (INSIGHT): Doctors review breast tissue samples using an AI tool that highlights suspicious areas needing closer attention.
* Group 2 (Conventional): Doctors review breast tissue samples without AI help, using the standard method.

This comparison will show if the AI-assisted method works better at finding invasive cancer.

What happens in the study?

* Researchers will use stored breast tissue samples already collected during the participant's surgery.
* Each sample will be randomly assigned to be reviewed using either the new AI-assisted method (Group 1) or the standard method (Group 2).
* In Group 1, an AI program will scan the tissue images first and point out areas that might contain invasive cancer for the doctor to check closely.
* In Group 2, doctors will review the tissue images without any AI help, using their standard process.
* Researchers will measure which method finds invasive cancer more accurately, how long the review takes, and how many additional tests (called IHC stains) are needed.

No new procedures are required from participants; the study uses existing tissue samples.

Eligibility criteria:
Inclusion Criteria:

* DCIS (ductal carcinoma in situ) with or without invasive carcinoma, as confirmed by core needle biopsy prior to surgery.
* Tumor size \>2 cm (cT2-cT4 according to AJCC 8th edition staging) with extensive calcifications, as documented by ultrasound or MRI.
* Undergone either mastectomy or breast-conserving surgery.
* Histopathological examination showing DCIS comprising ≥80% of the total tumor volume in the surgical specimen.

DCIS (ductal carcinoma in situ) with or without invasive carcinoma, as confirmed by core needle biopsy prior to surgery.

\- Minimum of 10 H\&E-stained slides available for each case, with adequate tissue quality for analysis.

Exclusion Criteria:

* Received neoadjuvant therapy (chemotherapy, endocrine therapy, or targeted therapy) before surgery.
* History of vacuum-assisted biopsy (VAB) or other minimally invasive breast procedures that may alter tumor architecture.
* Insufficient or degraded tissue samples (e.g., due to fixation artifacts, sectioning errors, or poor staining quality).
* Tumors lacking a DCIS (ductal carcinoma in situ) component upon histological examination.

Outcomes:
Diagnostic sensitivity