SERS Sensor Based on CHA Reaction for EGFR Mutation Typing in Advanced Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFuzhou General Hospital
About this trial
Summary:This study is a prospective, multicenter clinical study. In previous studies, we successfully constructed a CHA reaction-mediated self-calibrated SERS biosensor for the detection of EGFR mutation typing (Del-19, T790M, L858R) in lung cancer patients, and verified that the accuracy, sensitivity, and specificity of the SERS biosensor exceeded 95% in a small sample of 32 patients. In order to obtain the highest level of clinical evidence and truly achieve clinical transformation, this prospective, multicenter clinical study aims to verify the analytical efficiency of the SERS biosensor for EGFR mutation typing in patients with advanced lung cancer.
Purpose：This prospective, multicenter clinical study aims to verify the analytical efficacy of the previously constructed CHA reaction-mediated self-calibrated SERS biosensor in EGFR mutation typing in patients with advanced lung cancer.
Research subjects: The patients enrolled in this project are confirmed to be advanced non-small cell lung cancer (NSCLC). Enrollment will be completed in 25 centers and the enrollment will be competitive.
Research location: 900th Hospital of Joint Logistics Support Force Research intervention: None Study duration: Patients will be enrolled from June 2024 to June 2025. Subject participation time: Telephone follow-up will be conducted every three months until the end of the study.
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
Patients with other active malignant tumors;
Patients with missing baseline clinical data;
Patients with severe underlying lung diseases (such as bronchiectasis, bronchial asthma or COPD, etc.), or those with a history of occupational or environmental exposure to dust, mines or asbestos;
Participants who do not cooperate or refuse to participate in clinical trials at a later stage.
Trial population
Patients diagnosed with NSCLC by histological pathology and confirmed to be in advanced stage by clinical staging.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SERS sensor based on CHA reaction
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
400 Participants
are divided into 1 treatment groupGroup A: Patients diagnosed with advanced stage NSCLC by pathology1 intervention
Trial outcomes
Primary outcomes
1
NGS or RT-PCR
NGS or RT-PCR for EGFR mutation types
Time frame
through study completion, an average of 1 year2
Diagnostic accuracy
Determine the EGFR mutation type of cancer patients enrolled through the RAMAN intelligent diagnostic system
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
SERS(Surface-enhanced Raman spectroscopy) result
SERS sensor based on CHA reaction for EGFR mutation types
Time frame
through study completion, an average of 1 year2
Time to RAMAN diagnosis
The time to perform RAMAN testing and obtain diagnostic results after obtaining serum
Time frame
up to 30 days3
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
This trial is not recruiting at the moment. You can still explore other options: