DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma

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.

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Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prognostic Cancer Model Respiratory Tract Neoplasms Surgery Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210008, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Overall survival

Time frame: 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.

Secondary outcomes

Disease-free survival

Time frame: 4-year and/or 5-year after surgery completion

Subjects will be divided into high-risk and low-risk groups based on the DNA methylation model. The disease-free survival (DFS) 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 DFS between high-risk and low-risk groups that received further treatment and those that did not.

Sponsors and collaborators

Lead sponsor

Nanjing University

Other

Collaborators

Peking Union Medical College Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jun 27, 2024
Registry last updated: Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed