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

NCT ID: NCT06509555

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms TK1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PCR

non-intervention

Intervention Type OTHER

non-intervention

non-PCR

non-intervention

Intervention Type OTHER

non-intervention

Interventions

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non-intervention

non-intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yunnan Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qi Tang, doctor

Role: STUDY_CHAIR

Yunnan Cancer Hospital

Locations

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Yunnan Cancer Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xintong Zhao, Master Degree Candidate

Role: CONTACT

18008725197

Hui Li, master

Role: CONTACT

18468212816

Facility Contacts

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Hui Li, Master's degree

Role: primary

18468212816

Other Identifiers

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2024.0716

Identifier Type: -

Identifier Source: org_study_id

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