Clinical trial · Observational
SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type
SERS-Based Serum Molecular Spectral Screening for Non-Small Cell Lung Cancer vs. Small Cell Lung Cancer: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lung cancer can be divided into two major categories: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC accounting for about 85% and SCLC about 15%. The prognoses of different types of lung cancer vary significantly. Early identification of different pathological types of lung cancer is crucial to the patient's prognosis. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Non-Small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer Small Cell Lung Cancer (SCLC) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serum Raman spectroscopy intelligent diagnostic system | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Chest CT confirmed the presence of a pulmonary space-occupying lesion, which ultimately led to a lun
- description
- 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.
- interventionNames
- Diagnostic Test: Serum Raman spectroscopy intelligent diagnostic system
Primary outcomes (2)
- measure
- pathology
- timeFrame
- through study completion, an average of 1 year
- description
- The final pathology results of the lung lesion biopsy or post-surgery
- measure
- Diagnostic accuracy
- timeFrame
- through study completion, an average of 1 year
- description
- Determine whether the enrolled lung cancer patients are small cell lung cancer or non-small cell lung cancer through the RAMAN intelligent diagnostic system
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants with Lung cancer meeting the criteria of TNM (Ninth Edition); 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: 1. Participants with concomitant other malignant tumors; 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.
References
Publications (0)
Data not yet available