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EGFR_IUO 3.20 Clinical Study Protocol

NCT05959473 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-26

No results posted yet for this study

Summary

An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from FFPE Fine needle aspirate samples, using the Idylla EGFR\_IUO/3.20, from patients with Non-Small Cell Lung Cancer screened in AstraZeneca's NeoADAURA clinical trial (Protocol No. D516AC00001)

Conditions

Interventions

DEVICE

Idylla EGFR_IUO/3.20 Mutation Test

Clinical Performance Study Protocol for Idylla EGFR\_IUO/3.20 Mutation Test The EGFR\_IUO/3.20 is automated on the Idylla™ Platform, which executes the entire process from sample to result including sample liquefaction, cell lysis, real-time PCR amplification/detection, and data analysis and reporting.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Biocartis NV

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2023-12-18
Completion
2023-12-18
FDA Device
Yes

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05959473 on ClinicalTrials.gov