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

September 22, 2024 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Cancer Hospital Chinese Academy of Medical Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Meng Li, Doctor
  • Phone Number: 01087787532
  • Email: lmcams@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Detecting genomic and proteomic information
Other Names:
  • Phosphoproteomics
  • Deep-profiling tyrosine phosphorylation proteomics
  • Plasma proteomics
  • Plasma genomics
  • Whole-exome sequencing
Volunteers group
Healthy volunteers.
Diagnostic test: Mass spectrometry-based proteomics
Detecting genomic and proteomic information
Other Names:
  • Phosphoproteomics
  • Deep-profiling tyrosine phosphorylation proteomics
  • Plasma proteomics
  • Plasma genomics
  • Whole-exome sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of subsolid nodule invasive diagnosis
Time Frame: Through 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).
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Li Zhang, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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