NCT06509555

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 19, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

July 13, 2024

Last Update Submit

July 13, 2024

Conditions

Breast NeoplasmsTK1

Outcome Measures

Primary Outcomes (1)

  • Correlation analysis of serum TK1 and pathological remission of breast cancer with neoadjuvant chemotherapy

    2026.02

Study Arms (2)

PCR

Other: non-intervention

non-PCR

Other: non-intervention

Interventions

non-interventionOTHER

non-intervention

PCRnon-PCR

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient was diagnosed with breast cancer by biopsy.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Qi Tang, doctor

    Yunnan Cancer Hospital

    STUDY CHAIR

Central Study Contacts

Xintong Zhao, Master Degree Candidate

CONTACT

18008725197494784437@qq.com

Hui Li, master

CONTACT

1846821281618468212816@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2024

First Posted

July 19, 2024

Study Start

March 1, 2024

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

July 19, 2024

Record last verified: 2024-03

Locations

CN(1)