Clinical trial NCT06215885: Multi-omics Analysis to Characterize the Invasive Evolution of Pulmonary Subsolid Nodules
Official title: Cancer Hospital Chinese Academy of Medical Sciences
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenocarcinoma of Lung
Keywords: Subsolid nodule
Invasive evolution
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Accuracy of subsolid nodule invasive diagnosis
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Li Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: