Construction and validation of axillary lymph node metastasis prediction model for breast cancer
| ISRCTN | ISRCTN54288903 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54288903 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Hunan Provincial Science and Technology Department |
| Funder | Science and Technology Program of Hunan Province |
- Submission date
- 25/02/2024
- Registration date
- 27/02/2024
- Last edited
- 07/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Assessing axillary lymph node metastasis status and staging is crucial, but the accuracy of conventional clinical assessment methods is unsatisfactory. The researchers propose combining radiomics technology (to extract quantitative, and ideally reproducible, information from diagnostic images), machine learning algorithms and 3D visualization technology to construct a 3D visualization diagnosis and localization methods for axillary lymph nodes. This provides a new method for clinical axillary lymph node assessment of breast cancer.
Who can participate?
Female invasive breast cancer patients aged between 20-85 years old who had completed lung-enhanced CT and axillary lymph node dissection surgery.
What does the study involve?
Data will be retrospectively collected from all enrolled patients who underwent high-resolution thin-section enhanced CT of the lungs within 1 month before surgery. All patients had complete clinicopathological data, did not have distant metastases, and had not undergone neoadjuvant therapy (NAT).
What are the possible benefits and risks of participating?
A 3D visualization diagnosis and localization method will be constructed, which can effectively improve the predictive efficacy of assessing axillary lymph node status. Using medical records obtained from previous clinical visits for the study is consistent with minimal risk and will not adversely affect the rights or health of the participants.
Where is the study run from?
The Second Xiangya Hospital of Central South University.
When is the study starting and how long is it expected to run for?
January 2016 to January 2024
Who is funding the study?
The Science and Technology Innovation Program of Hunan Province (Grant No.2021SK2026).
Who is the main contact?
Prof. Wenjun Yi, yiwenjun@csu.edu.cn.
Contact information
Public, Scientific, Principal investigator
The Second Xiangya Hospital of Central South University, No. 139, Renmin Central Road
Changsha
410011
China
 ORCID ID |
0000-0002-1563-4925 |
|---|---|
| Phone | +8618608403318 |
| yiwenjun@csu.edu.cn |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-center diagnostic test |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Construction and application of three-dimensional visualization diagnosis method for axillary lymph nodes of breast cancer |
| Study objectives | Assessing axillary lymph node metastasis status and staging is crucial, but the accuracy of conventional clinical assessment methods is unsatisfactory. it is proposed that combining radiomics technology, machine learning algorithms and 3D visualization technology to construct 3D visualization diagnosis and localization methods for axillary lymph nodes. This provides a new method for clinical axillary lymph node assessment of breast cancer. |
| Ethics approval(s) |
Approved 28/03/2023, Clinical Research Ethics Committee, The Second Xiangya Hospital, Central South University (The Second Xiangya Hospital of Central South University, No. 139, Renmin Central Road, Changsha, 410011, China; +861 0731-85292476; xy2gcpduan@163.com), ref: LYF2023043 |
| Health condition(s) or problem(s) studied | Prediction of axillary lymph node metastasis in breast cancer patients |
| Intervention | Researchers will retrospectively collect data from invasive breast cancer patients who had completed lung-enhanced CT and axillary lymph node surgery. The researchers will construct a 3D axillary lymph node atlas using 3D visualization techniques. Researchers will localize and segment regions of interest (ROIs) from axillary lymph nodes, extract and select radiomic features, and construct axillary lymph node prediction models. |
| Intervention type | Other |
| Primary outcome measure(s) |
Predicting correct classification rate, sensitivity and specificity after axillary surgery measured using 3D visualization techniques to construct predictive models at one time point |
| Key secondary outcome measure(s) |
Predicting misclassification rate, false-positive rate and false-negative rate after axillary surgery measured using 3D visualization techniques to construct predictive models at one time point |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 85 Years |
| Sex | Female |
| Target sample size at registration | 1000 |
| Total final enrolment | 500 |
| Key inclusion criteria | 1. Underwent BC surgery at our hospital with postoperative pathology confirming invasive BC 2. Underwent axillary lymph node dissection (ALND) at our hospital 3. Completed a high-resolution, thin-section enhanced CT scan of the lung in our radiology department within one month before surgery 4. Had complete clinicopathological data |
| Key exclusion criteria | 1. Had bilateral primary or metastatic bc 2. Received neoadjuvant therapy (nat) before surgery 3. Had incomplete or poor-quality CT scans, flat scans only, or scans conducted externally 4. Had distant metastatic lesions or concurrent other malignancies |
| Date of first enrolment | 29/03/2023 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Changsha
410011
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2024 | 25/04/2025 | Yes | No | |
| Results article | 24/06/2025 | 07/07/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/07/2025: Publication reference added.
25/04/2025: Publication reference added.
26/02/2024: Study's existence confirmed by the Clinical Research Ethics Committee of The Second Xiangya Hospital, Central South University.
