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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04005677
Enrollment
500
Registered
2019-07-02
Start date
2018-07-01
Completion date
2024-12-31
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung; Node, Pulmonary Nodule, Solitary

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.

Interventions

DIAGNOSTIC_TESTThe 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Up-regulation of ctDNAthe first day subjects are enrolled the outcome will be assessed

Countries

China

Contacts

Primary Contactjinshuo fan
whxhfjs@hust.edu.cn+8615827367482

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026