What is this study trying to find out about lung cancer?

This study is evaluating a new way to monitor lung cancer recurrence after surgery by combining blood-based biological data with imaging and survival information. Researchers aim to develop a noninvasive method using artificial intelligence to predict which patients are more likely to experience cancer returning. The study is led by Peking University People's Hospital.

Who may be eligible for this lung cancer clinical trial?

Adults aged 18 to 85 years who have undergone radical surgery for non-small-cell lung cancer and completed neoadjuvant immunotherapy with chemotherapy may be eligible. Both males and females can participate, and those without pure ground-glass nodules on imaging are included. Please review eligibility criteria for more details.

Is there any cost to participate in this lung cancer clinical trial?

Study-related care, including all procedures and visits, is provided at no cost. However, personal expenses such as travel may not be covered and can vary. Participants should be prepared for possible out-of-pocket costs related to getting to the study site.

Actively Recruiting

Age: 18Years - 85Years

All Genders

ID07291921

Multi-omics Integrated Studies in Peripheral Blood to Establish Non-invasive Dynamic Follow-up Monitoring During Perioperative and Postoperative Periods for Lung Cancer Observational Study

Led by Peking University People's Hospital · Updated on 2026-03-03

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating a new way to monitor lung cancer recurrence after surgery by combining different types of biological data from blood samples. This includes plasma metabolomics, radiomics from CT images, and circulating free DNA cfDNA information, along with survival data, to create a noninvasive method using artificial intelligence. The study includes patients who have undergone radical surgery following neoadjuvant therapy for non-small-cell lung cancer NSCLC. The aim is to develop a predictive model that can accurately assess the risk of cancer returning. This observational study enrolls both retrospective and prospective groups of lung cancer patients who had surgery after neoadjuvant treatment. Blood samples are collected at multiple time points to analyze metabolites, and CT scans are used to extract radiomic features. Plasma cfDNA undergoes genome sequencing and methylation analysis to identify recurrence-related markers. Advanced machine learning techniques integrate these multi-omics datasets into a model that stratifies patients into high-risk and low-risk recurrence groups. Participants will provide blood samples and undergo CT imaging before and after surgery during follow-up visits. Researchers will evaluate the two-year recurrence-free survival rate as the primary outcome, alongside overall survival and the accuracy of the new minimal residual disease monitoring technique. The study will last several years to track patients clinical progression, aiming to improve noninvasive monitoring and personalized follow-up care after lung cancer surgery.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed written informed consent
Male or female aged 18 years or older and younger than 85 years
Underwent radical resection with pathologic stage IB-IIIA non-small-cell lung cancer
Tumor tissue and blood samples available at all required time points
No pure ground-glass nodules seen on imaging
Completed standard neoadjuvant immunotherapy with platinum-based chemotherapy

You will not qualify if you...

Postoperative pathology other than non-small-cell lung cancer, including benign lesions, small-cell carcinoma, metastasis, or unclear histology
Insufficient or poor-quality blood or tissue samples
Presence of pure ground-glass nodules on imaging
History of any other cancer within the past 5 years
Contraindications preventing radical surgery
Non-radical (R2) resection performed
Pathologic stage IIIB-N3, IIIC, or IV disease on tissue analysis
Refusal or withdrawal of informed consent
Any condition considered unsuitable by the investigator, such as blood transfusion during perioperative period or severe psychiatric disorder preventing follow-up

Research Team

Kezhong Chen

Yue He

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