SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type

NCT06775002 | Not Yet Recruiting DMC

• 1 other identifier: 2024-042
• Study Type: observational
• Target: 223
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

SERS; Raman; NSCLC; SCLC; diagnostic model

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Time to RAMAN diagnosis

  up to 30 days

• Safety assessment Results

  up to 30 days

Study Arms (1)

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

Interventions

Serum Raman spectroscopy intelligent diagnostic system DIAGNOSTIC_TEST

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.

Chest CT confirmed the presence of a pulmonary space-occupying lesion, which ultimately led to a lun

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants with Lung cancer meeting the criteria of TNM (Ninth Edition);
• Participants are willing to participate in this study and follow the research plan;
• Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;.

You may not qualify if:

• Participants with concomitant other malignant tumors;
• Participants with missing baseline clinical data;
• 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;
• Participants who are uncooperative or refuse to participate in the clinical trial later on.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zongyang Yu, Ph.D

CONTACT

13509327806; yuzy527@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: April 5, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: March 31, 2025

Record last verified: 2025-03