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Multi-omics Analysis to Characterize the Invasive Evolution of Pulmonary Subsolid Nodules

Cancer Hospital Chinese Academy of Medical Sciences

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06215885
Enrollment
220
Registered
2024-01-22
Start date
2024-01-22
Completion date
2024-12-31
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of Lung

Keywords

Subsolid nodule, Invasive evolution

Brief summary

Current clinical follow-up frequency and treatment timing for pulmonary subsolid nodules (SSNs) rely mostly on whether the nodules grow, which may not accurately reflect the pathological status, and may lead to unnecessary follow-ups. This study aims to use multi-omics techniques to dynamically observe the growth and invasiveness evolution process of SSNs and uncover its invasiveness mechanism. Radiological characteristics of SSNs in different invasiveness stages were also analyzed and summarized by analyzing preoperative CT. This can overcome the bottleneck of invasiveness assessment in the growth process of SSN and provide scientific evidence for the scientific management and clinical treatment timing choice of SSN patients, thus facilitating the rational allocation of medical resources and prolonging the expected survival of national health.

Detailed description

This prospective observational cohort study aims to recruit 120 patients with subsolid nodules (SSNs) and 100 healthy volunteers. Enroll 120 patients with SSNs planned for surgery and 100 healthy volunteers. Sequence blood and tissue samples from patients and compare the relevance of biomarkers between the two. Use blood from healthy volunteers as blank controls. Additionally, analyzes radiological characteristics of SSNs at different invasive stages using preoperative CT.

Interventions

DIAGNOSTIC_TESTMass spectrometry-based proteomics

Detecting genomic and proteomic information

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

Patients with SSNs 1. Newly diagnosed patients with persistent SSNs confirmed by thin-section chest CT examination 2. Patient areilling to undergo surgery 3. Voluntarily sign a written informed consent form Healthy Volunteers 1. Healthy volunteers aged 18-50 years, regardless of gender. 2. No lung nodules detected on chest thin-section CT. 3. No history of cancer. 4. Voluntary sign a written informed consent form.

Exclusion criteria

Patients with SSNs 1. Surgical contraindications 2. Inability to cooperate with CT/MR examination to obtain high-quality images 3. History of malignant tumors 4. Previous targeted, immune, or ablation therapy 5. Postoperative pathology of non-lung adenocarcinoma disease spectrum 6. Other situations deemed unsuitable for participation in this study by the researchers Healthy Volunteers 1. Drug abuse 2. HIV infection or AIDS 3. History of syphilis, gonorrhea, or other infectious diseases 4. Hepatitis B or C virus carrier

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of subsolid nodule invasive diagnosisThrough study completion, an average of 1 year.The efficacy of screening features for SSN invasiveness was compared to pathological diagnosis, using metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Countries

China

Contacts

Primary ContactLi Zhang, Doctor
zhangli_cams@163.com15010225989
Backup ContactMeng Li, Doctor
lmcams@163.com01087787532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026