Early stratified prediction of neoadjuvant therapy efficacy for breast cancer by radiopathomics models with key cell marking in tumor microenvironment

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400079678

Enrollment

Unknown

Registered

2024-01-09

Start date

2024-01-20

Completion date

Unknown

Last updated

2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Gold Standard:Pathological evaluation standards for breast cancer pathological tissue samples and neoadjuvant treatment efficacy of breast cancer: Histopathological specimens include biopsy pathology

RCB-I: small residual tumor

RCB-II: moderate residual tumor

RCB-III: extensive residual tumor).

Index test:(1) Quantitative parameters and imaging omics characteristics of multi temporal MRI images (2) Pathological WSI cell count, density quantitative characteristics, and spatial distribution ch

Eligibility

Sex/Gender

Female

Age

25 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with stage II-III breast cancer confirmed by pathological biopsy; (2) Complete pathological classification and grading, TNM staging, immunohistochemical tests (including ER, PR, HER2, Ki67) and related biochemical index tests (CEA, CA15-3 and CA125) before surgery; (3) No other treatment before neoadjuvant treatment; (4) The neoadjuvant treatment regimen is the I-line regimen recommended by CSCO guidelines; (5) Pre-treatment biopsy specimens are available.

Exclusion criteria

Exclusion criteria: (1) Related indicators before and after neoadjuvant therapy are incomplete; (2) The neoadjuvant treatment is not completed or the plan is not standardized; (3) Did not undergo surgery or cannot obtain postoperative pathological information; (4) The imaging examination is not standardized, the data is incomplete, or the image quality does not meet the analysis standard. (5) The MRI image shows occult cancer or the long diameter of the cancer focus is less than 1.0cm; (6) The pathological sections do not meet the analysis standards.

Design outcomes

Primary

Measure	Time frame
Quantitative parameters and radiomics features of longitudinal MRI images;Pathological WSI cell count, density quantitative characteristics, and spatial distribution characteristics of key cells in the tumor microenvironment;	—

Secondary

Measure	Time frame
Clinical and pathological features;	—

Countries

China

Contacts

Public ContactLina Zhang

The First Hospital of China Medical University;The Fourth Affiliated Hospital of China Medical University

zhanglnda@163.com+86 138 9812 2867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026