Colorectal Cancer, KRAS mutant Cancer
Conditions
Interventions
Sponsors
QIAGEN Manchester Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Archival tumor tissue sample (=5 years) or newly obtained (core needle, incisional, or excisional) biopsy of a tumor lesion not previously irradiated will be used to define KRAS G12C mutation status FFPE specimen must contain sufficient tumor tissue for testing as described in the therascreen® KRAS RGQ PCR kit instructions for use (DHF-22-0666-1-IFU) Sections must be submitted with >20% tumor content and tumor area > 4mm² (if required, macrodissection to be performed as stated in the IFU) Tumor tissue must be fixed in 10% neutral buffered formalin and embedded in paraffin (FFPE) Tumor samples must be from a FPPE block which may be submitted as either a block of fresh serially cut slides* If fresh serially cut slides are submitted: 4-5µm sections mounted on positively charged glass slides are expected Slides must be sectioned within 111 weeks of the testing date Consent should be obtained at the time of collection and not withdrawn at the time of the CDx testing** *only FPPE slides are accepted in China as per HGRAC policy **MSD remains responsible for ensuring subject has not withdrawn consent prior to sample analysis.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the MSD clinical trial can be found in the MK-1084-012 clinical trial protocol, section 5.2 Exclusion criteria: A specimen will be excluded from the performance study if any of the following criteria are true: Specimen with insufficient tumor tissue to perform the testing; Specimen submitted on uncharged or unknown slides; Specimen submitted on baked slides; Specimen is a fine needle aspirations (FNA), brushing, cell pellets from pleural effusion, bone biopsy or lavage sample; Specimen consists of tissue that has been decalcified; Incomplete or damaged labelling of the specimen; Specimen shows visible damage not related to macrodissection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The performance study endpoint is: Demonstration that the therascreen® KRAS RGQ PCR Kit is safe and effective to identify participants as G12C positive for MK-1084 treatment, as supported by the efficacy endpoints from the MK-1084-012 clinical trial. Efficacy of the Companion Diagnostic (CDx) and MK-1084 will be determined via assessment of progression free survival (PFS) as defined in the MSD MK-1084-012 Clinical Protocol and Statistical Analysis Plan. | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Singapore, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactS.J. Johnson
QIAGEN Manchester Limited
Outcome results
None listed