Axillary Lymph Node Metastasis / No Intervention: Observational Cohort / Breast Cancer · Observational Study

A Prospective Multicenter Study of the TuFEst-LN Model for Axillary Lymph Node Status Assessment in Breast Cancer

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a prospective multicenter observational cohort study planned to validate the TuFEst-LN model for preoperative assessment of axillary lymph node status in breast cancer. No results are yet available from this recruiting study.

What was studied

Observational. Breast Cancer, Axillary Lymph Node Metastasis; Female; age from 18 Years. Intervention: 1; 2. n = 400. 1 site: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for an ongoing observational cohort study with no results posted; it describes a planned validation of a diagnostic model in breast cancer staging.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Pathological axillary lymph node positivity rate among TuFEst-LN-negative patients (assessed at up to 2 weeks)

DesignObservational

PopulationBreast Cancer, Axillary Lymph Node Metastasis; Female; age from 18 Years

Sample size400

Intervention1; 2

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned sample size400

Primary outcome measurePathological axillary lymph node positivity rate among TuFEst-LN-negative patients

Follow-up timeframe for primary outcomeup to 2 weeks

Caveats

This is a registry record only; no results have been reported in ClinicalTrials.gov as of the date of this record
Study is currently recruiting; enrollment is estimated, not final
No information provided on methods, blinding, adjudication, or validation procedures
No effect sizes, sensitivity, specificity, or comparative performance data reported

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective multicenter observational cohort; no randomization or control group.

Directness

strong

Directly addresses axillary lymph node assessment in breast cancer patients undergoing surgery.

Consistency

insufficient

Registry record; no results reported, consistency cannot be assessed.

Risk of bias

insufficient

No methodology detail on blinding, adjudication, or verification; insufficient to assess.

Sample adequacy

moderate

Estimated enrollment 400 participants; adequate for observational validation but not yet recruited.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07304934). This is a study registration, not published results. Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Breast Cancer, Axillary Lymph Node Metastasis. Interventions: OTHER: No Intervention: Observational Cohort. Primary outcome measures: Pathological axillary lymph node positivity rate among TuFEst-LN-negative patients , up to 2 weeks. Brief summary: Through the research of this project, we expect to validate the clinical utility of the TuFEst-LN model in assessing axillary lymph node status in breast cancer patients. Specifically, we aim to prospectively validate its ability to identify pathologically node-negative patients among clinically and radiologically assessed cN0 patients undergoing upfront surgery ，and explore the predictive value of the TuFEst-LN model combined with preoperative MRI for ypN status assessment in initially node-positive patients following neoadjuvant therapy.

Follow from this

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NCT07304934Axillary Lymph Node MetastasisNo Intervention: Observational CohortSecond Affiliated Hospital, Zhejiang University, School of MedicineBreast Cancer