The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 29, 2022
April 1, 2022
4.5 years
June 23, 2019
April 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Up-regulation of ctDNA
the first day subjects are enrolled the outcome will be assessed
Study Arms (3)
lung cancer
benign lung nodule
lung nodule
Interventions
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.
Eligibility Criteria
Subjects enrolled are volenteered and are willing to be followed up.
You may qualify if:
- 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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 23, 2019
First Posted
July 2, 2019
Study Start
July 1, 2018
Primary Completion
December 31, 2022
Study Completion
December 31, 2024
Last Updated
April 29, 2022
Record last verified: 2022-04