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

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Pulmonary Nodule, Solitary; Lung; Node

Treatments: Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.

Study type: Observational

Funder types: Other

Identifiers

NCT04005677

Whuh2019 v.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

500 participants in 3 patient groups

lung cancer

Treatment:

Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.

benign lung nodule

Treatment:

Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.

lung nodule

Treatment:

Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.