SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFuzhou General Hospital

About this 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.

Eligibility criteria

Qualifiers

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;.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Serum Raman spectroscopy intelligent diagnostic system

Treatment groups

223 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators