Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation

NCT06573073 | Recruiting

• 1 other identifier: 202405068DSA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. Established in 2015, LifeOS Genomics Co., Ltd. stands among the select few domestic enterprises pioneering the autonomous development of digital Polymerase Chain Reaction (PCR) technology. The company's automated nucleic acid amplification quantitative analysis platform (QLoci™ md1000 Analyzer) demonstrates outstanding proficiency, featuring sixty thousand wells per PCR chip. Integrating digital PCR technology, it elevates analytical sensitivity beyond 0.1%. LifeOS commissioned the Core Laboratory of Pharmacogenomics at the National Taiwan University to conduct clinical validation assessments for their developed "EGFR T790M Mutation Detection Assay Kit." This assay kit secured official registration by the Taiwan Food and Drug Administration (TFDA) as a Laboratory Developed Test (LDT) in 2023, permitting the issuance of medical testing reports. This initiative aims to validate the detection capabilities of LifeOS Genomics Co., Ltd.'s "EGFR T790M Mutation Detection Assay Kit" prospectively clinically in clinical lung cancer patient plasma samples, addressing unmet clinical needs for early cancer detection, disease progression monitoring, and aiding physicians in diagnosis and pharmacotherapy.

Conditions

Non Small Cell Lung Cancer; EGFR T790M

Keywords

Liquid biopsy; digital Polymerase Chain Reaction (PCR); EGFR T790M

Outcome Measures

Primary Outcomes (1)

• Concordance in detecting EGFR T790M using the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2.

  The primary endpoint is to assess the concordance between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.

  5 years

Secondary Outcomes (2)

• Sensitivity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.

  5 years

• Specificity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.

  5 years

Study Arms (1)

NSCLC with EGFR mutation

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

Late stage NSCLC patients with EGFR activating mutations

You may qualify if:

• aged ≥18 years old.
• Patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations.

You may not qualify if:

• Pregnant women.
• Any condition that, in the opinion of the doctors, may pose a severe risk to the patient or interfere with trial results or participation.

Sponsors & Collaborators

• LifeOS Genomics Corporation: lead
• National Taiwan University: collaborator
• National Taiwan University Hospital: collaborator
• Chung Shan Medical University: collaborator
• Chang Gung Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator
• Far Eastern Memorial Hospital: collaborator

Study Sites (1)

National Taiwan University

Taipei, 10617, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sung-Liang Yu, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-Liang Yu, PhD

CONTACT

+886 23123456; slyu@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 27, 2024
• Study Start: September 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)