AI reads tumor slides to forecast cancer spread
NCT ID NCT07244094
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses artificial intelligence to analyze standard tissue samples from breast cancer patients. The goal is to predict which patients are at higher risk of the cancer spreading to other parts of the body. Researchers will train the AI on slides from 400 women who had surgery between 2015 and 2025. If successful, this tool could help doctors personalize follow-up care and treatment decisions.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study participants will be selected from a case-control cohort of adult female patients diagnosed with primary invasive breast cancer who underwent curative surgery at participating centers (e.g., The Second Affiliated Hospital of Zhejiang University) between January 2015 and December 2025. Eligible individuals must have available, high-quality archived primary tumor tissue samples, specifically H\&E-stained whole-slide images and consecutive sections for multiplex immunohistochemistry, coupled with complete clinicopathological data and long-term follow-up information documenting distant metastasis status. The final study sample will consist of patients from this source population who meet all predefined inclusion and exclusion criteria, ensuring data integrity and cohort homogeneity for AI model development.
- Ages
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18 to 95 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female patients aged 18 years or older. 2. Histologically confirmed primary invasive breast carcinoma. 3. Underwent curative surgical resection (mastectomy or breast-conserving surgery) between January 2015 and December 2025. 4. Before initiating the neoadjuvant therapy, there was a retention of the primary tumor specimen. 5. Availability of high-quality, digitizable Hematoxylin and Eosin (H\&E) stained whole-slide images (WSIs). 6. Availability of consecutive tissue sections from the same tumor block for multiplex immunohistochemistry (mIHC) staining (including markers such as Pan-CK, CD3, CD20). 7. Complete clinicopathological data and follow-up information must be available, including but not limited to: TNM stage, histological grade, molecular subtype (ER, PR, HER2 status), adjuvant treatment records, and clearly documented distant metastasis-free survival (DMFS) data. 8. A minimum follow-up of 5 years for patients with detailed information for distant metastasis events. Exclusion Criteria: 1. Pure ductal carcinoma in situ (DCIS) without an invasive component. 2. Special histological subtypes of invasive carcinoma (e.g., metaplastic carcinoma) with distinct biological behaviors. 3. No original lesion samples were retained before neoadjuvant therapy. 4. Presence of contralateral breast cancer or a history of any other prior malignancy (except for cured non-melanoma skin cancer or carcinoma in situ of the cervix). 5. H\&E or IHC slides with significant technical artifacts (e.g., fading, folds, heavy knife marks, tissue tearing, uneven staining) that preclude reliable image analysis. 6. Low tumor cellularity (e.g., tumor area \< 10% in the scanned field of view). 7. Unavailable or unalignable consecutive tissue sections, preventing spatial registration of H\&E and mIHC images. 8. Lack of essential clinicopathological or follow-up data required for model training or validation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
RECRUITINGHangzhou, Zhejiang, China
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Cancer Institute and Hospital, Tianjin Medical University, China
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Jilin Cancer Hospital
NOT_YET_RECRUITINGChangchun, Jilin, 130000, China
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
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