Lung CancerNCT05742204
Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer
An observational study of Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
We will identify plasma proteomics biomarkers for early diagnosis of lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Plasma protein biomarker analysis
- How many people
- 3,700 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study group: Patients with suspected or confirmed diagnosis of lung cancer. Control group: Non-cancer subjects including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.
Who may be able to join
- CT screening results showed that the size of pulmonary nodules was more than 5mm
- No treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.)
- Complete clinical and imaging data
- Chest CT/ low-dose spiral CT reports can be provided in the last 3 months
- Voluntarily sign informed consent
Who cannot join
- There is a history of tumor
- Clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc.
- Received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks
- Complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems
- Participated in other clinical trials within the last 3 months
- Combined with liver and kidney insufficiency, hypoproteinemia and other diseases affecting protein content
- You are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310009
About this study
Official title: Identification and Functional Verification Study in Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer
We will identify plasma proteomics biomarkers for early diagnosis of lung cancer.
Read the detailed description
We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Plasma protein biomarker analysis
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma protein biomarker analysisOther
Plasma samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment.We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients .
Plasma protein biomarker analysisOther
Plasma samples of control subjects were collected.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer group | Patients age over 18, with confirmed diagnosis of lung cancer. Receives: Other: Plasma protein biomarker analysis | |
| Control group | Non-cancer patients including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc. Receives: Other: Plasma protein biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma proteomic biomarkers
Plasma proteomic biomarkers for detection of lung cancer
Measured: 1 month after surgery
Model or classifier performance
Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer; and model or classifier performance including AUC, sensitivity, specificity, and accuracy
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Feb 2023
- Primary completion1 May 2025
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 3,700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weilin Wang, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742204
- Sponsor's protocol ID
- 2022-1109
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Functional Verification Study in Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT05742204
- Acronym / sponsor ID
- 2022-1109
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,700 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 23 Feb 2023 (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.
We will identify plasma proteomics biomarkers for early diagnosis of lung cancer.
Detailed description
We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer group | – | Other: Plasma protein biomarker analysisPatients age over 18, with confirmed diagnosis of lung cancer. |
| Control group | – | Other: Plasma protein biomarker analysisNon-cancer patients including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study group: Patients with suspected or confirmed diagnosis of lung cancer. Control group: Non-cancer subjects including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.
Key inclusion criteria (5 listed)
- CT screening results showed that the size of pulmonary nodules was more than 5mm
- No treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.)
- Complete clinical and imaging data
- Chest CT/ low-dose spiral CT reports can be provided in the last 3 months
- Voluntarily sign informed consent
Key exclusion criteria (7 listed)
- There is a history of tumor
- Clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc.
- Received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks
- Complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems
- Participated in other clinical trials within the last 3 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 |
|---|---|---|
| Plasma protein biomarker analysisPlasma samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment.We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients . | Other | Lung cancer group |
| Plasma protein biomarker analysisPlasma samples of control subjects were collected. | Other | Control group |
Primary outcome
Plasma proteomic biomarkers
Time frame: 1 month after surgery
Plasma proteomic biomarkers for detection of lung cancer
Model or classifier performance
Time frame: 1 month after surgery
Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer; and model or classifier performance including AUC, sensitivity, specificity, and accuracy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Weilin Wang study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University
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 Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma proteomic biomarkers (time frame: 1 month after surgery). The study lists 2 primary outcomes in all. 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 30 Sep 2026.