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NCT06772376

SERS Sensor Based on CHA Reaction for EGFR Mutation Typing in Advanced Lung Cancer

Not yet recruiting Last updated 31 March 2025
What this trial tests

trial testing SERS sensor based on CHA reaction in Lung Cancer in Normal and Malignant Tumors in 400 participants. Not yet recruiting.

Timeline
1 May 2026
Primary endpoint
1 June 2026
1 June 2026

Quick facts

Lead sponsorFuzhou General Hospital
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment400
Start date1 May 2026
Primary completion1 June 2026
Estimated completion1 June 2026

Drugs / interventions tested

Conditions studied

Sponsor

Fuzhou General Hospital

Who can join

18 and older, any sex, with Lung Cancer in Normal and Malignant Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Nanomaterial-Mediated Electrochemical and Optical Biosensors and Their Application in Tumour Marker Detection.
    Wang X, Hei J, Zhao T, Liu X, et al · · 2025 · PMID 41013140 · DOI 10.3390/s25185902

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Other Fuzhou General Hospital trials

Trials by the same sponsor.

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