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

NCT ID: NCT05965024

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 377 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2028-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Peng Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Peng Zhang, PhD

Role: primary

zhangpeng1121@tongji.edu.cn

02165115006

Other Identifiers

LungMate-016

Identifier Type: -

Identifier Source: org_study_id