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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06775002
Enrollment
223
Registered
2025-01-14
Start date
2026-04-05
Completion date
2026-11-20
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Non-Small Cell, Lung Cancer Small Cell Lung Cancer (SCLC)

Keywords

SERS, Raman, NSCLC, SCLC, diagnostic model

Brief summary

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.

Detailed 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. 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.

Interventions

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.

Sponsors

Fuzhou General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pathologythrough study completion, an average of 1 yearThe final pathology results of the lung lesion biopsy or post-surgery
Diagnostic accuracythrough study completion, an average of 1 yearDetermine whether the enrolled lung cancer patients are small cell lung cancer or non-small cell lung cancer through the RAMAN intelligent diagnostic system

Secondary

MeasureTime frameDescription
Time to RAMAN diagnosisup to 30 daysThe time to perform RAMAN testing and obtain diagnostic results after obtaining serum
Safety assessment Resultsup to 30 daysAEs and SAEs through Day 30

Contacts

Primary ContactZongyang Yu, Ph.D
yuzy527@sina.com13509327806

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026