Colo-rectal CancerNCT05347745
Therascreen® KRAS RGQ PCR Kit
A study testing therascreen® KRAS RGQ PCR Kit in people with Colo-rectal Cancer, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 99 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- therascreen® KRAS RGQ PCR Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pathologically documented metastatic colorectal cancer (CRC).
- Patients identified for inclusion in the Amgen Clinical Study (Protocol No. 20190172) who have signed and dated a valid informed consent form.
- 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:
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
QIAGEN Gaithersburg, Inc
Manchester, Manchester, M130BH
About this study
Official title: 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 KRAS G12C Mutation Into the Amgen Phase III Clinical Trial (Protocol No 20190172) to Demonstrate Clinical Performance of the Therascreen® KRAS RGQ PCR Kit.
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
Read the detailed description
This is an interventional, prospective clinical performance study protocol for the testing of DNA extracted from tumor tissue biopsy samples obtained from patients with CRC using the KRAS kit.
(RES, CNB are acceptable however (Fine needle aspiration (FNA), brushings, cell pellets from pleural effusion, bone biopsy and lavage samples are not acceptable.
Up to 200 patient tissue samples (from approximately 100 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190172), will be tested using the KRAS Kit. The testing will be performed at the l device clinical testing sites, Q2 Solutions Laboratories in the two geographical locations: USA and UK.
The clinical study protocol (Protocol No. 20190172) requires an estimated total of 153 evaluable patient tissue biopsy samples to be tested. Approximately 200 patient biopsy samples are expected to be supplied to the test sites to reach this target.
The KRAS G12C mutation status of patients enrolling on the clinical trial is expected to be known prior to patient screening hence the relatively low estimate of screen failures. If existing local data are used for patient selection, the archival tumor sample is requested to be sent to the Test Site for confirmation of KRAS G12C status prior to enrollment. For the US (Site 001) and EU (Site 002) Test Sites a FFPE tissue block (preferred) and a copy of the de-identified pathology report is requested by the Test Site or a minimum of 9 - 20 unstained slides (4-5 µm) should be submitted during screening for prospective central confirmation.
If no remaining tumor tissue is available from the biopsy used for determining KRAS G12C status then an alternative archival tumor sample may be submitted to the Test Site. If this is unavailable or if there is insufficient quality of tumor sample, a new biopsy will need to be provided for central KRAS G12C confirmation.
The primary objective of the Amgen Clinical Study is to evaluate the progression free survival assessed by MODIFIED RECIST 1.1 criteria of Sotorasib (AMG 510) at 2 different dose levels as a combination therapy with panitumumab, compared to patients treated with investigators choice comparator (trifluridine and tipiracil or regorafenib) in patients using the Clinical Study Assay, therascreen®KRAS Kit to assess the presence of the KRAS G12C mutation in CRC, a key eligibility criteria.
The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.
- Conditions
- Colo-rectal Cancer
- Being tested
- therascreen® KRAS RGQ PCR Kit
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therascreen® KRAS RGQ PCR KitDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: therascreen® KRAS RGQ PCR Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start7 Jan 2022
- Primary completion30 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347745
- Sponsor's protocol ID
- SMF-20-1839-1-001
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 KRAS G12C Mutation Into the Amgen Phase III Clinical Trial (Protocol No 20190172) to Demonstrate Clinical Performance of the Therascreen® KRAS RGQ PCR Kit.
- ClinicalTrials.gov ID
- NCT05347745
- Acronym / sponsor ID
- SMF-20-1839-1-001
- Conditions
- Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an interventional, prospective clinical performance study protocol for the testing of DNA extracted from tumor tissue biopsy samples obtained from patients with CRC using the KRAS kit.
(RES, CNB are acceptable however (Fine needle aspiration (FNA), brushings, cell pellets from pleural effusion, bone biopsy and lavage samples are not acceptable.
Up to 200 patient tissue samples (from approximately 100 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190172), will be tested using the KRAS Kit. The testing will be performed at the l device clinical testing sites, Q2 Solutions Laboratories in the two geographical locations: USA and UK.
The clinical study protocol (Protocol No. 20190172) requires an estimated total of 153 evaluable patient tissue biopsy samples to be tested. Approximately 200 patient biopsy samples are expected to be supplied to the test sites to reach this target.
The KRAS G12C mutation status of patients enrolling on the clinical trial is expected to be known prior to patient screening hence the relatively low estimate of screen failures. If existing local data are used for patient selection, the archival tumor sample is requested to be sent to the Test Site for confirmation of KRAS G12C status prior to enrollment. For the US (Site 001) and EU (Site 002) Test Sites a FFPE tissue block (preferred) and a copy of the de-identified pathology report is requested by the Test Site or a minimum of 9 - 20 unstained slides (4-5 µm) should be submitted during screening for prospective central confirmation.
If no remaining tumor tissue is available from the biopsy used for determining KRAS G12C status then an alternative archival tumor sample may be submitted to the Test Site. If this is unavailable or if there is insufficient quality of tumor sample, a new biopsy will need to be provided for central KRAS G12C confirmation.
The primary objective of the Amgen Clinical Study is to evaluate the progression free survival assessed by MODIFIED RECIST 1.1 criteria of Sotorasib (AMG 510) at 2 different dose levels as a combination therapy with panitumumab, compared to patients treated with investigators choice comparator (trifluridine and tipiracil or regorafenib) in patients using the Clinical Study Assay, therascreen®KRAS Kit to assess the presence of the KRAS G12C mutation in CRC, a key eligibility criteria.
The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit | Other | Diagnostic Test: therascreen® KRAS RGQ PCR KitThe 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 |
Who may qualify
- Ages
- 17 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with pathologically documented metastatic colorectal cancer (CRC).
- Patients identified for inclusion in the Amgen Clinical Study (Protocol No. 20190172) who have signed and dated a valid informed consent form.
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therascreen® KRAS RGQ PCR KitUtilize 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. | Diagnostic test | Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit |
Primary outcome
therascreen® KRAS RGQ PCR Kit
Time frame: 5 business days
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
The number of patients identified for enrollment into Amgen's Phase III clinical trial based on a KRAS G12C mutation detected test result.
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therascreen® KRAS RGQ PCR Kit in people with Colo-rectal Cancer, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
therascreen® KRAS RGQ PCR Kit (time frame: 5 business days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.