Therascreen® KRAS RGQ PCR Kit

NCT05347745 | Completed

• 1 other identifier: SMF-20-1839-1-001
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• therascreen® KRAS RGQ PCR Kit

  Device study is to 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

  5 business days

• The number of patients identified for enrollment into Amgen's Phase III clinical trial based on a KRAS G12C mutation detected test result.

  The primary objective of this device clinical performance study was to screen patients and confirm eligibility for enrollment into Amgen Phase III trail based on the detection of a KRAS G12C biomarker. If patents met all other eligibility criteria and were found to be KRAS G12C positive, they may enroll in the clinical trial. The primary outcome measure is the proportion pf patients tested with the QIAGEN therascreen KRAS RGQ PCR Kit that were KRAS G12C positive.

  12 months

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 (US) instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed, paraffin-embedded (FFPE), colorectal cancer (CRC) tissue

Diagnostic Test: therascreen® KRAS RGQ PCR Kit

Interventions

therascreen® KRAS RGQ PCR Kit DIAGNOSTIC_TEST

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.

Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit

Eligibility Criteria

• Age: 17 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically documented metastatic colorectal cancer (CRC).
• Patients must provide an archival tumor sample or a fresh tumor biopsy at baseline if an appropriate archival sample is unavailable.
• Local KRAS data must be available for patient selection.
• An archival tumor sample or fresh tumor biopsy is required for central confirmation of KRAS G12C status prior to enrollment.
• Patient samples must meet the following criteria:
• A formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) along with a de-identified pathology report.
• If an FFPE tissue block is unavailable, a minimum of 9-20 unstained slides (4-5 μm) must be submitted during screening for prospective central confirmation.
• If remaining tumor tissue from the KRAS status biopsy is unavailable, an alternative archival tumor sample may be submitted.
• If an alternative archival sample is unavailable or of insufficient quality, a new biopsy must be provided for central KRAS G12C confirmation.
• Submitted slides must be prepared using positively charged glass slides and cut within the past five years.
• Patient samples must have been collected using one of the following methods:
• Core needle biopsy (CNB)
• Surgical resection (RES)
• Lavage samples

You may not qualify if:

• Patients who do not meet all eligibility criteria for the Amgen Clinical Study (Protocol No. 20190172).
• Patients with samples collected using one of the following methods:
• Fine needle aspiration (FNA)
• Brushings
• Cell pellets from pleural effusion
• Bone biopsy

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead
• Amgen: collaborator

Study Sites (1)

QIAGEN Gaithersburg, Inc

Manchester, Manchester, M130BH, United Kingdom

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

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 20, 2022
• First Posted: April 26, 2022
• Study Start: January 7, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 24, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)