NCT07052734已完成不适用
A Multicenter Retrospective Analysis of the Miti-gene Recurrence Score in Early-Stage Invasive HR-Positive, HER2-Negative Breast Cancer in China
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 2,843 人开始时间: 2024年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,843
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed age: 18-75 years.
- •Early-stage invasive breast cancer, pN0-
- •Molecular subtype: HR-positive (ER and/or PR positive), HER2-negative.
- •At least five years of follow-up records (including cases with disease progression within five years and documented records).
- •Sufficient FFPE samples for sectioning or frozen samples for RNA extraction and subsequent testing.
排除标准
- •FFPE samples with tumor content <20%, and inability to enrich tumor regions through cutting.
- •Insufficient extracted nucleic acid quantity or severe degradation preventing further experiments.
- •Failure in RT-PCR amplification of housekeeping genes.
- •Multiple primary breast cancers or a history of ipsilateral or contralateral breast cancer.
- •Disease progression unrelated to breast cancer.
- •Lack of prior signed consent for retrospective scientific research or exemption from informed consent.
结局指标
主要结局
Disease-free survival
时间窗: 10 years
Disease-Free Survival (DFS) is defined as the duration from the completion of curative surgery until the first occurrence of any of the following events: local or distant relapse of the breast cancer, development of a new primary cancer, or death from any cause.
次要结局
- Distant relapse-free survival(10 years)
- Overall survival(10 years)
研究者
wang shusen
Professor
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
21-gene in Elder Breast Cancer Patients with Lymph Node MetastasisNCT06891651Qilu Hospital of Shandong University35
Unknown
不适用
Study to Compare Pathologic Type, NIH and WHO Criteria,and Mechanism of GIST Malignant TransformationMethod of Differentiating Benignancy and Malignancy, Grading and Staging for GISTNCT03381053Shanghai Zhongshan Hospital3,000
进行中（未招募）
不适用
Genomics in Michigan Impacting Observation or RadiationProstate CancerNCT02783950University of Michigan Rogel Cancer Center356
已完成
不适用
The Impact of the Gene Recurrence Score on Chemotherapy Prescribing in ER Positive, Lymph Node Positive Early Stage Breast CancerBreast CancerNCT03843346Cancer Trials Ireland87
已完成
不适用
Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant RecipientsInvasive Fungal DiseaseLung Transplant RecipientsInvasive Pulmonary AspergillosisPneumocystis Jirovecii PneumoniaNCT06654076Guangzhou Institute of Respiratory Disease109