SERS-Based Serum Molecular Spectral Detection of Invasive Lung Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer Patients
• 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): 200

Contacts and Locations

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

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • The 900th Hospital of the Joint Logistic Support Force, PLA
      • Contact: 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 reveals the presence of pulmonary nodules in the patient and plans to undergo surgical treatment.

Description

Inclusion Criteria:

1. Participants confirmed by chest CT to have pulmonary nodules
2. The diagnosis of participants with malignant pulmonary nodules must meet the TNM diagnostic criteria (Ninth Edition);
3. Participants are willing to participate in this study and follow the research plan;
4. 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 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;
4. Participants who do not cooperate or refuse to participate in clinical trials at a later stage.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Serum Raman spectroscopy intelligent diagnostic system; 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.

What is the study measuring?

Primary 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
Diagnostic accuracy	Determine whether there is hematogenous metastasis in enrolled lung cancer patients through RAMAN intelligent diagnostic system	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 4, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 5, 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: SERS，Raman，Early screening for lung cancer，Pulmonary nodule，diagnostic model
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2024-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

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