Analyzing the invasive evolution of lung nodules using multi-omics techniques

Cancer Hospital Chinese Academy of Medical Sciences

This study is testing how lung nodules grow and become more invasive by comparing samples from patients with these nodules to healthy volunteers to help improve treatment for those affected.

Quick facts

• Study type: Observational
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06215885 on ClinicalTrials.gov

What this trial studies

This observational study aims to recruit 120 patients with pulmonary subsolid nodules (SSNs) and 100 healthy volunteers to investigate the growth and invasiveness of SSNs using multi-omics analysis. By sequencing blood and tissue samples from patients and comparing them to healthy controls, the study seeks to uncover the mechanisms of invasiveness and assess radiological characteristics at different stages of invasion. The goal is to improve the management and treatment timing for patients with SSNs, potentially leading to better resource allocation and improved survival outcomes.

Who should consider this trial

Good fit: Ideal candidates include newly diagnosed patients with persistent SSNs who are willing to undergo surgery.

Not a fit: Patients with surgical contraindications or a history of malignant tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of lung nodules, reducing unnecessary follow-ups and improving patient management.

How similar studies have performed: While multi-omics approaches are gaining traction, this specific application to SSNs is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Li Zhang, Doctor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Li Zhang, Doctor

Conditions Adenocarcinoma of Lung; Subsolid nodule; Invasive evolution