NCT07060599Not yet recruiting
Human-AI Collaborative INSIGHT Diagnostic Workflow for in Breast Cancer With Extensive Intraductal Component
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)
Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- Aug 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Childhood cancers
- NCT number
- NCT07060599
What you commit to
- Study type: Interventional
- Planned participants: 480
- From Aug 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received neoadjuvant therapy (chemotherapy, endocrine therapy, or targeted therapy) before surgery.
Other illness
- History of vacuum-assisted biopsy (VAB) or other minimally invasive breast procedures that may alter tumor architecture.
Other
- 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.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.