Correlation Between Serum TK1 and Pathological Remission of Breast Cancer With Neoadjuvant Chemotherapy

Recruiting

• Conditions: Breast Neoplasms; TK1
• Interventions: Other: non-intervention

• Registration Number: NCT06509555
• Lead Sponsor: Yunnan Cancer Hospital

Brief Summary

The levels and changes of sTK1 among different outcome groups in BCs with different molecular types were compared by stratification to explore whether sTK1 can be used as one of the tumor markers to predict pathological remission of NACT in BC patients.The changes of serum sTK1 level and ADC before surgery were continuously monitored, and combined with other clinicopathological factors, the pathological remission prediction model of NACT in BC patients was constructed and verified.

Detailed Description

Female patients diagnosed with breast cancer by breast biopsy and receiving neoadjuvant chemotherapy in our hospital from 2020 to 2024 were selected as the study objects, and their puncture pathology data, general clinical characteristics, hematology test data, imaging data and surgical pathology data were collected, and the data were collated for statistical analysis. The influencing factors of pCR after neoadjuvant therapy were determined by univariate and multivariate logistic regression analysis, and the nomogram and ROC curve were drawn. The model was verified internally through bootstrap resampling 1000 times, and the correction curve was drawn to evaluate the prediction ability of the model.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-07-13
• Study First Submitted QC: 2024-07-13
• Last Update Submitted: 2024-07-13
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

① The patient was diagnosed with breast cancer by biopsy, and there were complete pathological data. ② Complete the course of neoadjuvant chemotherapy; ③ After the end of neoadjuvant therapy, the operation was performed and the postoperative pathology was obtained; MRI and serum TK1 data were complete (baseline, after 2 cycles of chemotherapy, 4 cycles of chemotherapy, and 6 cycles of chemotherapy).

Exclusion Criteria

① Distant metastasis at first diagnosis (stage IV); ② With other primary malignant tumors.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCR	non-intervention	-
non-PCR	non-intervention	-

Primary Outcome Measures

Name	Time	Method
Correlation analysis of serum TK1 and pathological remission of breast cancer with neoadjuvant chemotherapy	2026.02

Trial Locations

Locations (1)

Yunnan Cancer Hospital; 🇨🇳 Kunming, Yunnan, China