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

NCT06772376 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: 2024-045
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lung Cancer in Normal and Malignant Tumors

Keywords

SERS; CHA; EGFR; advanced lung cancer

Outcome Measures

Primary Outcomes (2)

• NGS or RT-PCR

  NGS or RT-PCR for EGFR mutation types

  through study completion, an average of 1 year

• Diagnostic accuracy

  Determine the EGFR mutation type of cancer patients enrolled through the RAMAN intelligent diagnostic system

  through study completion, an average of 1 year

Secondary Outcomes (3)

• SERS(Surface-enhanced Raman spectroscopy) result

  through study completion, an average of 1 year

• Time to RAMAN diagnosis

  up to 30 days

• Safety assessment Results

  up to 30 days

Study Arms (1)

Patients diagnosed with advanced stage NSCLC by pathology

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).

Diagnostic Test: SERS sensor based on CHA reaction

Interventions

SERS sensor based on CHA reaction DIAGNOSTIC_TEST

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.

Also known as: NGS, RT-PCR

Patients diagnosed with advanced stage NSCLC by pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with NSCLC by histological pathology and confirmed to be in advanced stage by clinical staging.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

MeSH Terms

Conditions

Neoplasms

Interventions

COVID-19 Nucleic Acid Testing

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Zongyang Yu, Ph.D

CONTACT

13509327806; yuzy527@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 13, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 31, 2025

Record last verified: 2025-03