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Standard management / Breast Cancer Lung Metastasis · Observational Study
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective observational study registration that aims to validate a six-gene risk score for predicting lung metastasis in early-stage breast cancer. No results are reported in this registry record; the study is not yet recruiting and remains in the planning phase.
Observational. Breast Cancer Lung Metastasis; Female; age from 18 Years; to 70 Years. Intervention: All Enrolled Early-Stage Breast Cancer Patients. Compared with: Risk stratification compared against traditional clinical indicators (TNM stage, molecular subtype, Ki-67).. n = 330. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (China; location inferred from sponsor name)..
This is a prospective observational study registration that aims to validate a six-gene risk score for predicting lung metastasis in early-stage breast cancer. No results are reported in this registry record; the study is not yet recruiting and remains in the planning phase.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a prospective observational study registration with no results posted; it is designed to validate a genetic risk model but carries no outcome data yet.
As stated by the source record.
Quoted from the source exactly as published.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07752966). This is a study registration, not published results. Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 330 participants (ESTIMATED). Conditions: Breast Cancer Lung Metastasis. Interventions: OTHER: Standard management. Primary outcome measures: Lung Metastasis Incidence , Up to 120 months; Area Under the Receiver Operating Characteristic (ROC) Curve of the Gene Risk Score for Predicting Lung Metastasis , Assessed at 1, 3, and 5 years (time-dependent ROC curves); Lung Metastasis-Free Survival and Overall Survival , Up to 120 months. Brief summary: The goal of this observational study is to validate the predictive ability of a six-gene risk score model for lung metastasis in patients with early-stage breast cancer. The main questions it aims to answer are: Does the gene risk score accurately identify patients at high risk of developing lung metastases? Does it predict lung metastasis-free survival and overall survival in these patients? How does its performance compare with traditional clinical indicators (such as TNM stage, molecular subtype, and Ki-67) across different breast cancer subtypes? Participants will be women aged 70 years or younger with newly diagnosed, non-metastatic early-stage breast cancer. They will receive standard treatment according to routine clinical practice. A single tumor tissue sample (from biopsy or surgery) will be collected for testing the expression of six specific genes, and a risk score will be calculated to classify patients into high-risk or low-risk groups. All participants will be followed for up to 120 months to monitor lung metastasis occurrence and survival outcomes. In addition, the study will explore differences in immune microenvironment characteristics between the two risk groups using a subset of tumor samples.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.