DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma

NCT06477211 | Completed

• 1 other identifier: Nanjing University
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Adenocarcinoma; Surgery; Prognostic Cancer Model

Keywords

DNA methylation; prognosis; LUAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disease-free survival

  4-year and/or 5-year after surgery completion

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung adenocarcinoma patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing University: lead
• Peking Union Medical College Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210008, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Qihan Chen, PhD

  Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 27, 2024
• Study Start: February 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 20, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

CN (1)