DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma

NCT ID: NCT06477211

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 292 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-01-20

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.

Conditions

Lung Adenocarcinoma; Surgery; Prognostic Cancer Model

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

PUMCH

LUAD patients who underwent surgical treatment and were followed up at Peking Union Medical College Hospital

No interventions assigned to this group

NDTH

LUAD patients who received surgical treatment and were followed up at Nanjing Drum Tower Hospital

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

Nanjing University

OTHER

Sponsor Role: lead

Responsible Party

Chen Qihan

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qihan Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing University

Locations

Nanjing Drum Tower hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

Nanjing University

Identifier Type: -

Identifier Source: org_study_id