DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Lung Adenocarcinoma; Prognostic Cancer Model

Detailed Description

• 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.

• Study Type: Observational
• Enrollment (Actual): 292

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Lung adenocarcinoma patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PUMCH; LUAD patients who underwent surgical treatment and were followed up at Peking Union Medical College Hospital
NDTH; LUAD patients who received surgical treatment and were followed up at Nanjing Drum Tower Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	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.	4years and/or 5years after surgery completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	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.	4-year and/or 5-year after surgery completion

Collaborators and Investigators

• Sponsor: Nanjing University
• Collaborators: Peking Union Medical College Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Principal Investigator: Qihan Chen, PhD, Nanjing University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: prognosis; DNA methylation; LUAD
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Adenocarcinoma of Lung; Adenocarcinoma
• Other Study ID Numbers: Nanjing University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No