A clinical performance study for testing FFPE tissue samples, with therascreen® KRAS RGQ PCR kit, to determine KRAS G12C mutation for potential enrollment into clinical study BO45217
- Conditions
- Long cancerNon small cell lung cancer (SCLC)10029107
- Registration Number
- NL-OMON56968
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 23
Tissue inclusion / exclusion criteria: Tumor specimens will be formalin-fixed,
paraffin-embedded (FFPE) in a paraffin block (preferred) or 10-15 (15
preferred) unstained, freshly cut, serial slides and should be of good quality,
with a minimum of 500 viable tumor cells. Samples collected via resection, core
needle biopsy, excisional, incisional, punch, or forceps biopsy, or
endobronchial ultrasound (EBUS)-transbronchial needle aspiration are
acceptable. Samples that do not preserve tissue architecture, including
fine-needle aspiration, brushing, cell pellets from pleural effusion, and
lavage samples are not acceptable. Tumor tissue from bone metastases that have
been decalcified is not acceptable.
Details on the inclusion criteria of the study subjects are described in
Section 5.1 of the clinical trial protocol for BO45217
Details on the exclusion criteria of the study subjects are described in
Section 5.1 of the clinical trial protocol for BO45217
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method