Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit
Phase 3 Multicentre, Prospective, Interventional Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit, From Patients With Non-Small Cell Lung Cancer, Screened in Clinical Study (Protocol No. 20190009).
1 other identifier
interventional
495
1 country
1
Brief Summary
An interventional, prospective study. It is estimated that up to 800 patient tissue samples (from approximately 650 patients enrolled at approximately 300 clinical trial sites), will be obtained as part of enrolment into Phase 3 of Clinical Study (Protocol No. 20190009), for testing using the therascreen® KRAS RGQ PCR Kit (KRAS Kit).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable nonsmall-cell-lung-cancer
Started Mar 2020
Shorter than P25 for not_applicable nonsmall-cell-lung-cancer
1 active site
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
Study Start
First participant enrolled
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2021
CompletedFirst Submitted
Initial submission to the registry
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedNovember 4, 2024
October 1, 2024
1.1 years
April 1, 2022
November 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
therascreen® KRAS RGQ PCR Kit (KRAS Kit).
To utilize the Clinical Trial Assay, the (KRAS Kit), as a screening test in Phase 3 of Clinical Study (Protocol No. 20190009), in order to identify patients with NSCLC who have the KRAS G12C mutation.
5 business days
Study Arms (1)
Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit
OTHERThe KRAS Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of somatic G12C mutations in the human KRAS oncogene using DNA extracted from formalin fixed paraffin-embedded (FFPE) Non-small Cell Lung Cancer (NSCLC) tissue. The KRAS Kit is intended to aid in the identification of cancer patients who may be eligible for treatment with AMG 510.
Interventions
To utilize a Clinical Study assay, the therascreen® KRAS RGQ PCR Kit, as a screening test in Phase 3 of Clinical Study (Protocol No. 20190009), in order to identify patients with NSCLC with KRAS G12C mutation positive tumours.
Eligibility Criteria
You may qualify if:
- All patients who provided consent (by signing and dating the ICF for Protocol No. 20190009), may be included in the Clinical Performance Study.
You may not qualify if:
- Patients whose tumour tissue biopsy samples are not Clinical Study Assay evaluable will be asked to provide further tumour tissue biopsy samples. Patients with samples identified for the study which have insufficient testing material will have their sample excluded, as will specimens which have undergone decalcification.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- QIAGEN Gaithersburg, Inclead
- Amgencollaborator
Study Sites (1)
QIAGEN Gaithersburg, Inc
Manchester, M130BH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2022
First Posted
April 26, 2022
Study Start
March 13, 2020
Primary Completion
April 22, 2021
Study Completion
April 22, 2021
Last Updated
November 4, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share