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

NCT ID: NCT04005677

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Nodule, Solitary Lung; Node

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lung cancer

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yang Jin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jinshuo fan

Role: CONTACT

+8615827367482

Facility Contacts

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Yang Jin, MD

Role: primary

Other Identifiers

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Whuh2019 v.1

Identifier Type: -

Identifier Source: org_study_id

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