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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Serum Raman spectroscopy intelligent diagnostic system
Diagnostic test1\. 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.
Treatment groups
223 Participants
are divided into 1 treatment groupGroup A: Chest CT confirmed the presence of a pulmonary space-occupying lesion, which ultimately led to a lun1 intervention
Trial outcomes
Primary outcomes
1
pathology
The final pathology results of the lung lesion biopsy or post-surgery
Time frame
through study completion, an average of 1 year2
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
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Time to RAMAN diagnosis
The time to perform RAMAN testing and obtain diagnostic results after obtaining serum
Time frame
up to 30 days2
Safety assessment Results
AEs and SAEs through Day 30
Time frame
up to 30 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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