New Method to Differentiate Benign and Malignant Pulmonary Nodules.

NCT06056999 | Recruiting

• 2 other identifiers: 2023-KY-02772023-NHLHCRF-YYPPLC-ZR-02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (\<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.

Conditions

Pulmonary Nodules

Keywords

differential diagnosis; benign and malignant pulmonary nodules; early diagnosis of lung cancer

Outcome Measures

Primary Outcomes (1)

• Establish an model for differentiating lung nodules.

  To establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) image analysis.

  6 months

Study Arms (3)

A. pure ground-glass nodule

Patients with pure ground-glass nodules (GGNs).

B. part-solid nodule

Patients with part-solid nodules (PSNs).

C. solid nodule

Patients with solid nodules (SNs).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary nodule \<3cm who are admitted to China-Japan Friendship Hospital and are scheduled for puncture biopsy or surgery.

You may qualify if:

• Age ≥18 years;
• CT imaging shows the presence of pulmonary nodule \<3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed;
• Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2;
• Subjects with fair vital organ function, defined as: white blood cells ≥3.0×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine \<178μmol/L;
• Subjects must have the ability to understand and sign the informed consent in writing voluntarily.

You may not qualify if:

• Imaging examination have suggested the possibility of metastasis at other sites;
• ≥2 target lesions with different type categorized by density;
• History of malignant disease;
• Severe vascular lesions within the last 3 months, or known significant active infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled;
• The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.;
• History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, that may affect the signing of informed consent;
• Pregnant or breastfeeding women;
• Other conditions deemed by the investigator to be unsuitable for enrollment.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guangying Zhu

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangying Zhu, doctor

CONTACT

+86-010-84205381; zryyfa@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 29, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available starting 6 months and ending 5 years following article publication.
• Access Criteria: People who provide reasonable research protocols can get access to the data by contacting the researchers.

Locations

CN (1)