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

Pulmonary Nodule, Solitary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005677
• Other study ID #: Whuh2019 v.1
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Wuhan Union Hospital, China
• Contact: jinshuo fan
• Phone: +8615827367482
• Email: whxhfjs[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung; Node
• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Diagnostic Test:
• The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.
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 to analyze the ctDNA, RNA, protein, metabolites, immune status and their relationships with the tumorigenesis and the gene mutation of lung cancer.

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Up-regulation of ctDNA		the first day subjects are enrolled the outcome will be assessed