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

Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05965024

Enrollment

377

Registered

2023-07-28

Start date

2023-10-25

Completion date

2028-08-31

Last updated

2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
2-year recurrence-free survival rate	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.

Secondary

Measure	Time frame	Description
Median recurrence-free survival	up to 60 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. Median recurrence-free survival means the median value of recurrence-free survival.

Countries

China

Outcome results