Non-small Cell Lung CancerNCT05965024
Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer patients underwent radical surgery, explore… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 377 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2023to Aug 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB
Who may be able to join
- Age ≥ 18 years old, regardless of gender;
- Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB;
- Able to undergo radical surgical treatment;
- Physical condition score (ECOG) ≤1;
- The expected survival time exceeds 24 months;
- Volunteer to participate in this study and sign an informed consent form.
Who cannot join
- Individuals with a history of other malignant tumors within 5 years;
- Those who have undergone neoadjuvant therapy before surgery;
- Postoperative incision margin R1 or incision margin R2;
- Those who have undergone a blood transfusion within 2 weeks before the surgery;
- Individuals with systemic inflammatory response syndrome;
- Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain;
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- Participants in other clinical trials within the past 30 days and have taken investigational drugs;
- Due to various reasons, sampling cannot be completed, samples do not meet the requirements, or baseline samples (preoperative and postoperative plasma samples, tumor tissue samples) are incomplete;
- Researchers believe that it is not appropriate to participate in this experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Peng Zhang, PhD, 02165115006, zhangpeng1121@tongji.edu.cn
About this study
Official title: Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer patients underwent radical surgery, explore personalized analysis models, and conduct research on recurrence monitoring for non-small cell lung cancer patients.
- Conditions
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival rate
Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. 2-year recurrence-free survival rate means the rate of patients survive without recurrence for 2 years or more.
Measured: Up to 24 months
Secondary outcomes (1)
Median recurrence-free survival
Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. Median recurrence-free survival means the median value of recurrence-free survival.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start25 Oct 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 377 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965024
- Sponsor's protocol ID
- LungMate-016
- Status last verified
- Feb 2024
- First submitted
- 20 Jul 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05965024
- Acronym / sponsor ID
- LungMate-016
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 377 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Jul 2023 (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.
Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer patients underwent radical surgery, explore personalized analysis models, and conduct research on recurrence monitoring for non-small cell lung cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, regardless of gender;
- Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB;
- Able to undergo radical surgical treatment;
- Physical condition score (ECOG) ≤1;
- The expected survival time exceeds 24 months;
Key exclusion criteria (9 listed)
- Individuals with a history of other malignant tumors within 5 years;
- Those who have undergone neoadjuvant therapy before surgery;
- Postoperative incision margin R1 or incision margin R2;
- Those who have undergone a blood transfusion within 2 weeks before the surgery;
- Individuals with systemic inflammatory response syndrome;
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
2-year recurrence-free survival rate
Time frame: Up to 24 months
Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. 2-year recurrence-free survival rate means the rate of patients survive without recurrence for 2 years or more.
1 secondary outcome
Median recurrence-free survival
Time frame: up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival rate (time frame: Up to 24 months). 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 21 Feb 2024.