NCT05959473

Brief 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)

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

July 17, 2023

Last Update Submit

January 25, 2024

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    EGFR\_IUO/3.20 as a screening test in Phase 3 of clinical trial (Protocol D516AC00001), in order to identify patients (with NSCLC) with EGFR mutation positive (Exon 19 deletion and/or L858R) for inclusion in study (D516AC00001)

    7 business days

Interventions

Idylla EGFR_IUO/3.20 Mutation TestDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who provided consent (by signing and dating the Consent Form for AstraZeneca NeoADAURA Protocol No. D516AC00001), may be included in the device study.

You may not qualify if:

  • Patients whose FFPE FNA samples are not Clinical Trial Assay evaluable will be excluded from the study.
  • Patients with samples identified for the study which have insufficient testing material will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Specimens from NSCLC patient with FFPE FNA samples, will be extracted and tested with the Idylla EGFR\ IUO/3.20.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

September 1, 2023

Primary Completion

December 18, 2023

Study Completion

December 18, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01