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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: jinshuo fan; Phone Number: +8615827367482; Email: whxhfjs@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled are volenteered and are willing to be followed up.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lung cancer	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.
benign lung nodule	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.
lung nodule	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Up-regulation of ctDNA	the first day subjects are enrolled the outcome will be assessed

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: June 23, 2019
• First Submitted That Met QC Criteria: June 29, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: Whuh2019 v.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No