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

NCT ID: NCT06215885

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-22

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenocarcinoma of Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Mass spectrometry-based proteomics

Intervention Type DIAGNOSTIC_TEST

Detecting genomic and proteomic information

Volunteers group

Healthy volunteers.

Mass spectrometry-based proteomics

Intervention Type DIAGNOSTIC_TEST

Detecting genomic and proteomic information

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mass spectrometry-based proteomics

Detecting genomic and proteomic information

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Phosphoproteomics Deep-profiling tyrosine phosphorylation proteomics Plasma proteomics Plasma genomics Whole-exome sequencing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Li Zhang, Doctor

Role: CONTACT

15010225989

Meng Li, Doctor

Role: CONTACT

01087787532

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Li Zhang, Doctor

Role: primary

15010225989

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCC4258

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.