MedTrace Logo

Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

NCT05348187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2024-11-04

No results posted yet for this study

Summary

An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer and Colorectal Cancer, screened in Amgen's clinical trial (Protocol No. 20170543).

Conditions

Interventions

DIAGNOSTIC_TEST

therascreen® KRAS RGQ PCR Kit

The primary objective is to utilize a clinical trial assay, the therascreen® KRAS RGQ PCR Kit, as a screening test in Phase 2 of Amgen clinical trial, in order to identify patients (with NSCLC and CRC) with KRAS G12C mutation positive tumors

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • QIAGEN Gaithersburg, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-11-23
Completion
2020-11-23

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT05348187 on ClinicalTrials.gov