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临床试验/NCT06477211
NCT06477211已完成不适用

A Multicenter Retrospective Study Identifying DNA 5mC Predictors for LUAD Prognosis

Nanjing University1 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2024年2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
292
试验地点
1
主要终点
Overall survival

研究概览

简要总结

This study is designed to assess DNA 5-methylcytosine (5mC) methylation modifications in lung adenocarcinoma (LUAD) samples and develop a prognosis-predictive model for LUAD based on cancer tissue DNA 5mC levels. The research will link post-surgical recurrence and survival outcomes to the DNA 5mC profiles of patients. By collaborating with two hospitals in China, this multicentral study will utilize over three years of prognostic data from LUAD patients to validate the model's accuracy. Additionally, the research aims to explore the potential of the model in guiding adjuvant treatment strategies by comparing the differences in outcomes between high-risk patients who receive further treatment and those who do not. This study aspires to enhance future treatment planning for LUAD patients, providing personalized and effective therapeutic options based on precise prognostic predictions.

详细描述

  • Model Development

  • The methylation data will be analyzed to identify specific 5mC methylation patterns associated with post-surgical recurrence and survival outcomes.

  • A prognostic model will be developed based on these methylation profiles to predict LUAD prognosis.

  • Model Validation

  • Clinical data from LUAD patients at two hospitals in China, including over three years of follow-up information, will be used to validate the accuracy and reliability of the prognostic model.

  • Statistical methods will be applied to assess the model's predictive power and its ability to accurately stratify patients into different risk categories.

  • Exploration of Follow-up and Adjuvant Therapy Guidance

  • The study will compare outcomes between high-risk patients who receive additional adjuvant treatment and those who do not, based on the risk categories identified by the prognostic model.

  • This comparison aims to explore the model's potential in guiding adjuvant therapy decisions, ultimately enhancing personalized treatment strategies and improving survival rates for LUAD patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Histologically confirmed early-stage lung adenocarcinoma, or clinically diagnosed early-stage lung adenocarcinoma.
  • Underwent surgical treatment
  • Cancer tissues well paraffin-embedded or cryopreserved

排除标准

  • Diagnosed with other serious illnesses
  • Received other treatments before surgery
  • Surgery to remove multiple cancerous tissues

结局指标

主要结局

Overall survival

时间窗: 4years and/or 5years after surgery completion

Subjects will be divided into high-risk and low-risk groups based on the DNA methylation model. The overall survival (OS) of these two groups will be compared to determine if there is a significant difference. Additionally, we will analyze whether there are significant differences in OS between high-risk and low-risk groups that received further treatment and those that did not.

次要结局

  • Disease-free survival(4-year and/or 5-year after surgery completion)

研究者

发起方
Nanjing University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Qihan

Research Assistant

Nanjing University

研究点 (1)

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