Clinical trial NCT06775002: SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer, Non-Small Cell
Lung Cancer Small Cell Lung Cancer (SCLC)
Keywords: SERS
Raman
NSCLC
SCLC
diagnostic model
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pathology
timeFrame: through study completion, an average of 1 year
measure: Diagnostic accuracy
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Time to RAMAN diagnosis
timeFrame: up to 30 days
measure: Safety assessment Results
timeFrame: up to 30 days
Other outcomes:
Locations:
Study officials:
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