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Therascreen® KRAS RGQ PCR Kit

NCT05347745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2025-03-24

No results posted yet for this study

Summary

An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from patients with Colorectal Cancer (CRC) who have previously tested positive for the KRAS G12C mutation for potential inclusion into the Amgen Phase III clinical trial (Protocol No 20190172) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit

Conditions

  • Colo-rectal Cancer

Interventions

DIAGNOSTIC_TEST

therascreen® KRAS RGQ PCR Kit

Utilize a Clinical Trial Assay, the KRAS Kit, as a screening test in Phase 3 of Clinical Study (Protocol No. 20190172) in order to identify patients with CRC with KRAS G12C mutation positive tumors This will allow the clinical data from the study to be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • QIAGEN Gaithersburg, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2023-03-30
Completion
2023-04-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT05347745 on ClinicalTrials.gov