Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma(PDAC), Non-Small Cell Lung Cancer (NSCLC), or other solid tumor Colon cancer, pancreatic cancer, lung cancer, other solid tumors
Conditions
Interventions
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Details on the inclusion and exclusion criteria of the study subjects are described in Section 5.2 of the clinical trial protocol for GO45416.TISSUE INCLUSION CRITERIA: A representative FFPE tumor specimen in a paraffin block (preferred) or at least 7 freshly cut unstained slides for screening and 8-15 freshly cut unstained slides (15 slides preferred) for all participants should be submitted along with an associated pathology report.If participants do not have prior local results for KRAS G12D mutational status, the mandatory tumor tissue specimen must be submitted during screening for central biomarker assessment of eligibility. For participants enrolling based on prior local test results for KRAS G12D mutation status, the mandatory tumor tissue sample must be confirmed available during screening and shipped to the central laboratory within 30 days of enrollment.Tumor tissue should be of good quality, as determined based on total and viable tumor content. Samples must contain a minimum of 500 viable tumor cells that preserve cellular context and tissue architecture regardless of needle gauge or retrieval method. Samples collected via resection, core-needle biopsy (at least three cores, embedded in a single paraffin block), or excisional, incisional, punch, or forceps biopsy are acceptable.If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, the participant may undergo a biopsy at screening if the biopsy site is safely accessible. A pre-treatment tumor biopsy may also be performed if an individual's archival tissue test results do not meet eligibility criteria.
Exclusion criteria
Exclusion criteria: Details on the inclusion and exclusion criteria of the study subjects are described in Section 5.3 of the clinical trial protocol for GO45416.TISSUE EXCLUSION CRITERIA: Fine needle aspiration (defined as samples that do not preserve tissue architecture and yield cell suspension and/or smears), brushing, cell pellets from pleural effusion, and lavage samples are not acceptable. Tumor tissue from bone metastases that have been decalcified is not evaluable for KRAS G12D mutation by molecular testing and is, therefore, not acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for the use of the therascreen KRAS RGQ PCR kit are assessment of the number of samples tested and KRAS G12D positivity rate. | — |
Countries
Australia, Canada, France, Germany, Israel, Italy, Netherlands, Singapore, South Korea, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Acc. Clinical Trial Regulatory Management, Product Development Regulatory
Hoffmann-La Roche
Outcome results
None listed