Lung Cancer PatientsNCT06775015
SERS-Based Serum Molecular Spectral Detection of Invasive Lung Cancer
An observational study of Lung Cancer Patients, run by Fuzhou General Hospital at 1 site in China.
Trial summary
Surgery is the main treatment for early lung cancer. It is worth noting that there are significant differences in postoperative prognosis and surgical methods between microinvasive cancer and early-stage invasive cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Patients
- What is being tested?
- Serum Raman spectroscopy intelligent diagnostic system
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2026to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chest CT reveals the presence of pulmonary nodules in the patient and plans to undergo surgical treatment.
Who may be able to join
- Participants confirmed by chest CT to have pulmonary nodules
- The diagnosis of participants with malignant pulmonary nodules must meet the TNM diagnostic criteria (Ninth Edition);
- Participants are willing to participate in this study and follow the research plan;
- Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;
Who cannot join
- Participants with concomitant other malignant tumors;
- Participants with missing baseline clinical data;
- Participants with severe underlying lung diseases (such as bronchiectasis, bronchial asthma or COPD, etc.), or those with a history of occupational or environmental exposure to dust, mines or asbestos;
- Participants who do not cooperate or refuse to participate in clinical trials at a later stage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The 900th Hospital of the Joint Logistic Support Force, PLA
Fuzhou, Fujian, 350025
Zongyang Yu, Ph.D, 13509327806, yuzy527@sina.com
About this study
Official title: SERS-Based Serum Molecular Spectral Detection of Lung Cancer Microinvasion Versus Invasion Screening: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial
Surgery is the main treatment for early lung cancer. It is worth noting that there are significant differences in postoperative prognosis and surgical methods between microinvasive cancer and early-stage invasive cancer. Micro invasive lung cancer can achieve 100% long-term survival through surgical resection, without the need for postoperative adjuvant radiotherapy. There is no need to remove lung lobes during surgery, only segmental or wedge resection is required, and systematic lymph node dissection is not recommended. Therefore, accurate prediction of preoperative and intraoperative microinvasive cancer and invasive cancer in pulmonary nodules is crucial for patients to choose surgical methods, which can significantly affect postoperative lung function retention and overall survival.
Raman spectroscopy (RS), as a non-invasive and highly specific molecular detection technique, can be obtained at the molecular level to sensitively detect changes in biomolecules composed of proteins, nucleic acids, lipids, and sugars related to tumor metabolism in biological samples. The surface enhanced Raman spectroscopy (SERS) developed based on this technology is one of the feasible methods for high-sensitivity biomolecule analysis.
We collected serum Raman spectroscopy data from a cohort of 138 early lung cancer patients in our preliminary research. Based on a machine learning model, we constructed an early lung microinvasive cancer and invasive cancer Raman intelligent diagnosis system, which achieved an accuracy rate of 89.4%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical study aims to validate the use of this intelligent diagnostic system for early diagnosis of lung cancer and the discrimination between microinvasive cancer and invasive cancer.
Read the detailed description
- Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
- Completion of baseline procedures, participants were assessed for 30 days and completed all safety monitoring.
- After completing the baseline assessment and confirming enrollment, participants will be given 2ml of fasting venous blood.
- Conditions
- Lung Cancer Patients
- Being tested
- Serum Raman spectroscopy intelligent diagnostic system
- Keywords
- SERS，Raman，Early screening for lung cancer，Pulmonary nodule，diagnostic model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Raman spectroscopy intelligent diagnostic systemDiagnostic test
Serum Raman spectroscopy intelligent diagnostic system Description: 1. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. The following is the general sequence of events during the 3 months evaluation period: 4. Completion of baseline procedures Participants were assessed for 3 months and completed all safety monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent chest CT scans and were found to have lung nodules | Chest CT confirmed the presence of pulmonary nodules in the patient and ultimately underwent surgical intervention. The pulmonary nodules had the final pathological results. Receives: Diagnostic Test: Serum Raman spectroscopy intelligent diagnostic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Determine whether there is hematogenous metastasis in enrolled lung cancer patients through RAMAN intelligent diagnostic system
Measured: through study completion, an average of 1 year
Time to RAMAN diagnosis
The time to perform RAMAN testing and obtain diagnostic results after obtaining serum
Measured: up to 30 days
Secondary outcomes (1)
Safety assessment Results
AEs and SAEs through Day 30
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start4 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PatientsStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775015
- Sponsor's protocol ID
- 2024-043
- Status last verified
- Mar 2025
- First submitted
- 5 Jan 2025
- Last updated
- 31 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERS-Based Serum Molecular Spectral Detection of Lung Cancer Microinvasion Versus Invasion Screening: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial
- ClinicalTrials.gov ID
- NCT06775015
- Acronym / sponsor ID
- 2024-043
- Conditions
- Lung Cancer Patients
- Keywords
- SERS，Raman，Early screening for lung cancer，Pulmonary nodule，diagnostic model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- 4 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2025 (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.
Surgery is the main treatment for early lung cancer. It is worth noting that there are significant differences in postoperative prognosis and surgical methods between microinvasive cancer and early-stage invasive cancer. Micro invasive lung cancer can achieve 100% long-term survival through surgical resection, without the need for postoperative adjuvant radiotherapy. There is no need to remove lung lobes during surgery, only segmental or wedge resection is required, and systematic lymph node dissection is not recommended. Therefore, accurate prediction of preoperative and intraoperative microinvasive cancer and invasive cancer in pulmonary nodules is crucial for patients to choose surgical methods, which can significantly affect postoperative lung function retention and overall survival.
Raman spectroscopy (RS), as a non-invasive and highly specific molecular detection technique, can be obtained at the molecular level to sensitively detect changes in biomolecules composed of proteins, nucleic acids, lipids, and sugars related to tumor metabolism in biological samples. The surface enhanced Raman spectroscopy (SERS) developed based on this technology is one of the feasible methods for high-sensitivity biomolecule analysis.
We collected serum Raman spectroscopy data from a cohort of 138 early lung cancer patients in our preliminary research. Based on a machine learning model, we constructed an early lung microinvasive cancer and invasive cancer Raman intelligent diagnosis system, which achieved an accuracy rate of 89.4%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical study aims to validate the use of this intelligent diagnostic system for early diagnosis of lung cancer and the discrimination between microinvasive cancer and invasive cancer.
Detailed description
- Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
- Completion of baseline procedures, participants were assessed for 30 days and completed all safety monitoring.
- After completing the baseline assessment and confirming enrollment, participants will be given 2ml of fasting venous blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent chest CT scans and were found to have lung nodules | – | Diagnostic Test: Serum Raman spectroscopy intelligent diagnostic systemChest CT confirmed the presence of pulmonary nodules in the patient and ultimately underwent surgical intervention. The pulmonary nodules had the final pathological results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chest CT reveals the presence of pulmonary nodules in the patient and plans to undergo surgical treatment.
Key inclusion criteria (4 listed)
- Participants confirmed by chest CT to have pulmonary nodules
- The diagnosis of participants with malignant pulmonary nodules must meet the TNM diagnostic criteria (Ninth Edition);
- Participants are willing to participate in this study and follow the research plan;
- Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;
Key exclusion criteria (4 listed)
- Participants with concomitant other malignant tumors;
- Participants with missing baseline clinical data;
- Participants with severe underlying lung diseases (such as bronchiectasis, bronchial asthma or COPD, etc.), or those with a history of occupational or environmental exposure to dust, mines or asbestos;
- Participants who do not cooperate or refuse to participate in clinical trials at a later stage.
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 |
|---|---|---|
| Serum Raman spectroscopy intelligent diagnostic systemSerum Raman spectroscopy intelligent diagnostic system Description: 1. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. The following is the general sequence of events during the 3 months evaluation period: 4. Completion of baseline procedures Participants were assessed for 3 months and completed all safety monitoring. | Diagnostic test | Patients who underwent chest CT scans and were found to have lung nodules |
Primary outcome
Diagnostic accuracy
Time frame: through study completion, an average of 1 year
Determine whether there is hematogenous metastasis in enrolled lung cancer patients through RAMAN intelligent diagnostic system
Time to RAMAN diagnosis
Time frame: up to 30 days
The time to perform RAMAN testing and obtain diagnostic results after obtaining serum
1 secondary outcome
Safety assessment Results
Time frame: up to 30 days
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 31 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Patients, run by Fuzhou General Hospital 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Mar 2025. 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?
Contact Zongyang Yu, Ph.D (13509327806, yuzy527@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: through study completion, an average of 1 year). 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 31 Mar 2025.