Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

NCT05348187 | Completed

• 1 other identifier: QMAN-18-0181-1-001
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief 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

Non-Small Cell Lung Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• therascreen® KRAS RGQ PCR Kit

  therascreen® KRAS RGQ PCR Kit, as a screening test in Phase 2 of clinical trial (Protocol 20170543), in order to identify patients (with NSCLC and CRC) with KRAS G12C mutation positive tumors for inclusion in study (Protocol 20170543)

  5 business days

Study Arms (1)

Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit

OTHER

The therascreen KRAS RGQ PCR 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) Colorectal Cancer (CRC) and Non-small Cell Lung Cancer (NSCLC) tissue. The therascreen KRAS RGQ PCR Kit is intended to aid in the identification of cancer patients who may be eligible for treatment with AMG 510.

Diagnostic Test: therascreen® KRAS RGQ PCR Kit

Interventions

therascreen® KRAS RGQ PCR Kit DIAGNOSTIC_TEST

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

Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who provided consent (by signing and dating the Consent Form for Amgen Protocol No. 20170543), may be included in the device study.

You may not qualify if:

• Patients whose tumor tissue biopsy samples are not Clinical Trial Assay evaluable will be excluded from the study. Additionally, patients with samples identified for the study which have insufficient testing material will also be excluded, as will specimens which have undergone decalcification.

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead
• Amgen: collaborator

Study Sites (1)

QIAGEN Gaithersburg, Inc

Manchester, M130BH, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Specimens from advanced NSCLC and CRC patient tumor samples, will be extracted and tested with the therascreen® KRAS RGQ PCR Kit. The sample KRAS G12C mutation status, if known by a previous testing method, will be blinded to device investigation site personnel at NeoGenomics.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 27, 2022
• Study Start: July 1, 2019
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)