Clinical trial NCT06477211: DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma
Official title: A Multicenter Retrospective Study Identifying DNA 5mC Predictors for LUAD Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Adenocarcinoma
Surgery
Prognostic Cancer Model
Keywords: DNA methylation
prognosis
LUAD
Lead sponsor: Nanjing University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2024-06-27
Enrollment: 292
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung adenocarcinoma patients

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: 4years and/or 5years after surgery completion
Secondary outcomes:
measure: Disease-free survival
timeFrame: 4-year and/or 5-year after surgery completion
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower hospital
state: Jiangsu
Study officials:
affiliation: Nanjing University
name: Qihan Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: