Lung AdenocarcinomaNCT06477211
DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma
An observational study of Lung Adenocarcinoma and Surgery, run by Nanjing University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Adenocarcinoma, Surgery, Prognostic Cancer Model
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lung adenocarcinoma patients
Who may be able to join
- Histologically confirmed early-stage lung adenocarcinoma, or clinically diagnosed early-stage lung adenocarcinoma.
- Underwent surgical treatment
- Cancer tissues well paraffin-embedded or cryopreserved
Who cannot join
- Diagnosed with other serious illnesses
- Received other treatments before surgery
- Surgery to remove multiple cancerous tissues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- DNA methylation, prognosis, LUAD
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4years and/or 5years after surgery completion
Secondary outcomes (1)
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.
Measured: 4-year and/or 5-year after surgery completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Feb 2024
- Primary completion20 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Chen Qihan, Nanjing University
- Investigators
- Qihan Chen, PhD, Principal investigator, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477211
- Sponsor's protocol ID
- Nanjing University
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Study Identifying DNA 5mC Predictors for LUAD Prognosis
- ClinicalTrials.gov ID
- NCT06477211
- Acronym / sponsor ID
- Nanjing University
- Conditions
- Lung Adenocarcinoma, Surgery, Prognostic Cancer Model
- Keywords
- DNA methylation, prognosis, LUAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lung adenocarcinoma patients
Key inclusion criteria (3 listed)
- Histologically confirmed early-stage lung adenocarcinoma, or clinically diagnosed early-stage lung adenocarcinoma.
- Underwent surgical treatment
- Cancer tissues well paraffin-embedded or cryopreserved
Key exclusion criteria (3 listed)
- Diagnosed with other serious illnesses
- Received other treatments before surgery
- Surgery to remove multiple cancerous tissues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 4years and/or 5years after surgery completion
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.
1 secondary outcome
Disease-free survival
Time frame: 4-year and/or 5-year after surgery completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qihan Chen, PhD principal investigator
Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma and Surgery, run by Nanjing University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 4years and/or 5years after surgery completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.