To Conduct Multi-omics Integrated Studies in Peripheral Blood, Such as Fragment Omics, Metabolomics and Epigenetics, and Establish Non-invasive Dynamic Follow-up Monitoring Programs During Perioperative and Postoperative Periods (Observational Study)

NCT07291921 | Recruiting

• 1 other identifier: BRWEP2024W034080204-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to innovatively integrate multi-omics data, including plasma metabolomics, radiomics, and cfDNA multi-level information, combined with survival data (e.g., RFS), to establish a novel multidimensional approach for noninvasive postoperative recurrence monitoring in lung cancer using artificial intelligence algorithms. The goal is to develop a new noninvasive recurrence monitoring system for lung cancer.

Conditions

Lung Neoplasms; Neoadjuvant Therapy; Immunotherapy; Minimal Residual Disease

Keywords

NSCLC; Neoadjuvant immunotherapy; Perioperative monitoring; Liquid biopsy; MRD; Minimal residual disease; Multiple omics

Outcome Measures

Primary Outcomes (1)

• Two-year recurrence-free survival rate

  Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years

Secondary Outcomes (2)

• Overall survival

  Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.

• Timely diagnosis rate by the novel MRD monitoring technique

  two years

Study Arms (2)

High-risk group

High-risk recurrence groups identified by the multi-omics model

Low-risk group

Low-risk recurrence groups identified by the multi-omics model

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary nodules who underwent radical treatment at our center between May 2025 and October 2027, met all eligibility criteria, and provided informed consent.

You may qualify if:

• Signed written informed consent.
• Male or female, aged ≥ 18 and \< 85 years.
• Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.
• Tumor tissue and blood samples obtainable at all protocol-specified time-points.
• No pure ground-glass nodule on imaging.
• Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.

You may not qualify if:

• Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate/inadequate histology.
• Insufficient or poor-quality blood or tissue samples.
• Pure ground-glass nodule on imaging.
• History of any malignancy within the past 5 years.
• Contraindication to surgery preventing radical resection.
• Non-radical (R2) resection.
• Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.
• Refusal or withdrawal of informed consent.
• Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kezhong Chen

CONTACT

+86-010-88325983; mdkzchen@163.com

Yue He

CONTACT

+86-010-88325983; hy771999@163.com

Study Design

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

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2025-12

Locations

CN (1)