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

Shanghai Pulmonary Hospital, Shanghai, China

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05965024

LungMate-016

Details and patient eligibility

About

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.

Enrollment: 377 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.