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

NCT05965024 | Recruiting

• 1 other identifier: LungMate-016
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Median recurrence-free survival

  up to 60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (1)