Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965024
• Other study ID #: LungMate-016
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: August 2028

Study information

• Verified date: February 2024
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 personalized analysis models, and conduct research on recurrence monitoring for non-small cell lung cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 377
• Est. completion date: August 2028
• Est. primary completion date: August 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old, regardless of gender;

2. Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB;

3. Able to undergo radical surgical treatment;

4. Physical condition score (ECOG) =1;

5. The expected survival time exceeds 24 months;

6. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Individuals with a history of other malignant tumors within 5 years;

2. Those who have undergone neoadjuvant therapy before surgery;

3. Postoperative incision margin R1 or incision margin R2;

4. Those who have undergone a blood transfusion within 2 weeks before the surgery;

5. Individuals with systemic inflammatory response syndrome;

6. Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain;

7. Participants in other clinical trials within the past 30 days and have taken investigational drugs;

8. 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;

9. Researchers believe that it is not appropriate to participate in this experiment.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Recurrence

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 months
Secondary	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.	up to 60 months