Pulmonary Nodule, SolitaryNCT04005677
The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
An observational study of Pulmonary Nodule, Solitary and Lung; Node, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Nodule, Solitary, Lung; Node
- What is being tested?
- The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects enrolled are volenteered and are willing to be followed up.
Who may be able to join
- 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;
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- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yang Jin, MD
About this study
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.
Read the 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.
- Conditions
- Pulmonary Nodule, Solitary, Lung; Node
- Being tested
- The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected.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.
| Study group | Role | What they receive |
|---|---|---|
| lung cancer | Not described Receives: Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected. | |
| benign lung nodule | Not described Receives: Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected. | |
| lung nodule | Not described Receives: Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Up-regulation of ctDNA
Measured: the first day subjects are enrolled the outcome will be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jul 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005677
- Sponsor's protocol ID
- Whuh2019 v.1
- Status last verified
- Apr 2022
- First submitted
- 23 Jun 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
- ClinicalTrials.gov ID
- NCT04005677
- Acronym / sponsor ID
- Whuh2019 v.1
- Conditions
- Pulmonary Nodule, Solitary, Lung; Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lung cancer | – | Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected. |
| benign lung nodule | – | Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected. |
| lung nodule | – | Diagnostic Test: The serum, plasma, urine, faeces, peripheral blood mononuclear cell (PBMC), exhaled breath condensate and the clinical characteristics are collected. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects enrolled are volenteered and are willing to be followed up.
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | benign lung nodule, lung cancer, lung nodule |
Primary outcome
Up-regulation of ctDNA
Time frame: the first day subjects are enrolled the outcome will be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Solitary and Lung; Node, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jinshuo fan (+8615827367482, whxhfjs@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Up-regulation of ctDNA (time frame: the first day subjects are enrolled the outcome will be assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.