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)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: High-risk group
Group B: Low-risk group

Trial outcomes

Primary outcomes

1

Two-year recurrence-free survival rate

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

Secondary outcomes

1

Overall survival

Time frame
Time from curative surgery to confirmation of death (any cause),assessed up to 60 months.
2

Timely diagnosis rate by the novel MRD monitoring technique

The proportion of patients with recurrence signals detected by non-invasive methods prior to clinical confirmation of recurrence/metastasis, and quantify the mean lead time.

Time frame
two years

Other outcomes

Sponsors and contacts

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