The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages

Recruiting

• Conditions: Pulmonary Nodule, Solitary; Lung; Node
• Interventions: Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.

• Registration Number: NCT04005677
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

The researchers are aimed to investigate the early diagnosis of pulmonary nodule based on DNA, RNA, protein, metabolites through analyzing the serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and clinical characteristics.

Detailed Description

By recruiting people with pulmonary nodules identified by CT scans, three groups are confirmed as the lung cancer group, the benign lung nodule group who are identified by pathological analysis, and the small lung nodule group that should be followed up. Then the serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics including age, sex, smoking status, BMI, address, greening environment and the laboratory tests are collected to analyze the ctDNA, RNA, protein, metabolites, immune status and their relationships with the tumorigenesis and the gene mutation of lung cancer.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2019-06-23
• Study First Submitted QC: 2019-06-29
• Study First Posted: 2019-07-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-29
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

For lung cancer groups

• (1) Patients diagnosed with lung cancer;
• (2) Clear diagnosis by pathological examination to determine pathological type;
• (3) Those aged 18-80 years old;
• (4) For patients with newly diagnosed lung cancer, CT confirmed that the size of primary lung cancer is ≤ 3 cm;
• (5) The patient or family member agrees to participate in the study and sign an informed consent form;
• (6) No other serious cardiopulmonary diseases. For lung nodule
• (1) Those aged 18-80 years;
• (2) CT clear lung nodule size ≤ 3cm;
• (3) 1-3cm pulmonary nodules confirmed by pathological diagnosis as non-lung cancer or other metastatic cancer patients or ≤1cm pulmonary nodules
• (4) The patient or family member agrees to participate in the study and sign an informed consent form;
• (5) No other serious cardiopulmonary diseases.

Exclusion Criteria

• (1) Women who are breast-feeding, pregnant or preparing for pregnancy;
• (2) Those who are allergic to allergies and multiple drugs;
• (3) Combining severe primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematopoietic system, as well as subjects with mental illness;
• (4) concurrently infected;
• (5) Those who participated in other clinical trials within three months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
benign lung nodule	The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.	-
lung nodule	The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.	-
lung cancer	The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.	-

Primary Outcome Measures

Name	Time	Method
Up-regulation of ctDNA	the first day subjects are enrolled the outcome will be assessed

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China