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DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06477211
Enrollment
292
Registered
2024-06-27
Start date
2024-02-01
Completion date
2025-01-20
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Adenocarcinoma, Prognostic Cancer Model, Surgery

Keywords

DNA methylation, prognosis, LUAD

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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival4years and/or 5years after surgery completionSubjects 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

MeasureTime frameDescription
Disease-free survival4-year and/or 5-year after surgery completionSubjects 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026