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

NCT06215885 | Unknown

• 1 other identifier: NCC4258
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of Lung

Keywords

Subsolid nodule; Invasive evolution

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Subsolid nodules group

Patients with pulmonary subsolid nodules were identified by CT examination and intended for surgical treatment. All participants will undergo chest CT, genomic, and proteomic tests to identify related biomarkers and establish a clinical diagnostic model for the invasiveness of subsolid nodules.

Diagnostic Test: Mass spectrometry-based proteomics

Volunteers group

Healthy volunteers.

Diagnostic Test: Mass spectrometry-based proteomics

Interventions

Mass spectrometry-based proteomics DIAGNOSTIC_TEST

Detecting genomic and proteomic information

Also known as: Phosphoproteomics, Deep-profiling tyrosine phosphorylation proteomics, Plasma proteomics, Plasma genomics, Whole-exome sequencing

Subsolid nodules group; Volunteers group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent chest CT examination and found SSN and planned to undergo surgical treatment from November 2023 to September 2024 and Healthy volunteers.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Exome

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Li Zhang, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, Doctor

CONTACT

15010225989; zhangli_cams@163.com

Meng Li, Doctor

CONTACT

01087787532; lmcams@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 22, 2024
• Study Start: January 22, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 24, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)