SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
- Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
- Completion of baseline procedures, participants were assessed for 30 days and completed all safety monitoring.
- After completing the baseline assessment and confirming enrollment, participants will be given 2ml of fasting venous blood.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: 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
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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;.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 |
|---|---|---|
|
pathology
Time Frame: through study completion, an average of 1 year
|
The final pathology results of the lung lesion biopsy or post-surgery
|
through study completion, an average of 1 year
|
|
Diagnostic accuracy
Time Frame: through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to RAMAN diagnosis
Time Frame: up to 30 days
|
The time to perform RAMAN testing and obtain diagnostic results after obtaining serum
|
up to 30 days
|
|
Safety assessment Results
Time Frame: up to 30 days
|
AEs and SAEs through Day 30
|
up to 30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-042
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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