Examining serum TK1 levels to predict breast cancer treatment outcomes
Establishment of Serum TK1 Combined With MRI to Predict Pathological Remission of Breast Cancer With Neoadjuvant Chemotherapy
This study is testing if measuring a specific protein in the blood can help predict how well breast cancer patients will respond to their chemotherapy treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yunnan Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT06509555 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the correlation between serum thymidine kinase 1 (sTK1) levels and pathological remission in breast cancer patients undergoing neoadjuvant chemotherapy. Female patients diagnosed with breast cancer will have their clinical and pathological data collected and analyzed to determine the predictive value of sTK1 levels for treatment outcomes. The study employs statistical methods, including logistic regression and ROC curve analysis, to develop and validate a prediction model for pathological complete response (pCR) based on sTK1 and other clinical factors.
Who should consider this trial
Good fit: Ideal candidates are female patients diagnosed with breast cancer who are receiving neoadjuvant chemotherapy and have complete pathological data.
Not a fit: Patients with distant metastasis at diagnosis or those with other primary malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for predicting treatment response in breast cancer patients, potentially leading to more personalized treatment strategies.
How similar studies have performed: While the approach of using serum biomarkers for treatment prediction is established, the specific focus on sTK1 in this context is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kunming, Yunnan
- Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Xintong Zhao, Master Degree Candidate
- Email: 494784437@qq.com
- Phone: 18008725197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.