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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer, Non-Small Cell; Lung Cancer Small Cell Lung Cancer (SCLC)
• Intervention / Treatment: Diagnostic test: Serum Raman spectroscopy intelligent diagnostic system

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.

• Study Type: Observational
• Enrollment (Estimated): 223

Contacts and Locations

• Study Contact: Name: Zongyang Yu, Ph.D; Phone Number: 13509327806; Email: yuzy527@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathology	The final pathology results of the lung lesion biopsy or post-surgery	through study completion, an average of 1 year
Diagnostic accuracy	Determine whether the enrolled lung cancer patients are small cell lung cancer or non-small cell lung cancer through the RAMAN intelligent diagnostic system	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to RAMAN diagnosis	The time to perform RAMAN testing and obtain diagnostic results after obtaining serum	up to 30 days
Safety assessment Results	AEs and SAEs through Day 30	up to 30 days

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; SCLC; Raman; SERS; diagnostic model
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
• Other Study ID Numbers: 2024-042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No