Clinical trial · Observational
SERS Sensor Based on CHA Reaction for EGFR Mutation Typing in Advanced Lung Cancer
SERS Sensor Based on CHA Reaction for EGFR Mutation Typing in Advanced Lung Cancer: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer in Normal and Malignant Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SERS sensor based on CHA reaction | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with advanced stage NSCLC by pathology
- description
- The study was conducted in 25 centers across the country, recruiting 200 patients with advanced NSCLC with different confirmed EGFR mutation types (Del-19, L858R, T790M, and no gene mutation).
- interventionNames
- Diagnostic Test: SERS sensor based on CHA reaction
Primary outcomes (2)
- measure
- NGS or RT-PCR
- timeFrame
- through study completion, an average of 1 year
- description
- NGS or RT-PCR for EGFR mutation types
- measure
- Diagnostic accuracy
- timeFrame
- through study completion, an average of 1 year
- description
- Determine the EGFR mutation type of cancer patients enrolled through the RAMAN intelligent diagnostic system
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. Patients with other active malignant tumors; 2. Patients with missing baseline clinical data; 3. 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; 4. Participants who do not cooperate or refuse to participate in clinical trials at a later stage.
References
Publications (0)
Data not yet available