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

Adenocarcinoma of Lung Clinical Trial

Official title:

Cancer Hospital Chinese Academy of Medical Sciences

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215885
• Other study ID #: NCC4258
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Li Zhang, Doctor
• Phone: 15010225989
• Email: zhangli_cams[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma of Lung

Intervention

Diagnostic Test:
• Mass spectrometry-based proteomics
Detecting genomic and proteomic information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of subsolid nodule invasive diagnosis	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).	Through study completion, an average of 1 year.