SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type
NCT ID: NCT06775002
Last Updated: 2025-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
223 participants
OBSERVATIONAL
2026-04-05
2026-11-20
Brief Summary
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Raman Spectrum (RS), as a non-invasive and highly specific molecular detection technique, can obtain information at the molecular level, thereby sensitively detecting changes in biomolecules related to tumor metabolism such as proteins, nucleic acids, lipids, and sugars. Surface-enhanced Raman spectroscopy (SERS), developed based on this technology, is one of the feasible methods for high-sensitivity biomolecular analysis.
In preliminary study, the investigators collected serum Raman spectral data from a cohort of 233 patients with malignant lung tumors and built a Raman intelligent diagnostic system for SCLC and NSCLC based on a machine learning model, achieving an accuracy rate of 80%. 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 the early diagnosis of SCLC.
Detailed Description
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2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
3. Completion of baseline procedures, participants were assessed for 30 days and completed all safety monitoring.
4. After completing the baseline assessment and confirming enrollment, participants will be given 2ml of fasting venous blood.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chest CT confirmed the presence of a pulmonary space-occupying lesion, which ultimately led to a lun
Chest CT confirmed the presence of a pulmonary space-occupying lesion, which ultimately led to a lung biopsy or surgical intervention. Pathology indicated a malignant lung tumor.
Serum Raman spectroscopy intelligent diagnostic system
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.
Interventions
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Serum Raman spectroscopy intelligent diagnostic system
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.
Eligibility Criteria
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Inclusion Criteria
2. Participants are willing to participate in this study and follow the research plan;
3. Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;.
Exclusion Criteria
2. Participants with missing baseline clinical data;
3. Participants with severe underlying pulmonary diseases (such as bronchiectasis, bronchial asthma, or COPD), or those with a history of occupational or environmental exposure to dust, mines, or asbestos;
4. Participants who are uncooperative or refuse to participate in the clinical trial later on.
18 Years
ALL
No
Sponsors
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Fuzhou General Hospital
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2024-042
Identifier Type: -
Identifier Source: org_study_id