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Evaluation of a Genetic Risk Score for Lung Metastasis and Prognosis in Breast Cancer

NCT07752966 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2026-08-07

No results posted yet for this study

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.

Conditions

  • Breast Cancer Lung Metastasis

Interventions

OTHER

Standard management

Standard Management

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2038-10-01
Completion
2038-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07752966 on ClinicalTrials.gov