[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565673":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"QIAGEN Gaithersburg, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit","OTHER","The therascreen® KRAS RGQ PCR Kit functions as part of this system, using the QIAamp DSP DNA FFPE Kit as a clinical sample concentrator, the Rotor-Gene Q MDx (RGQ) instrument as the platform on which PCR is performed, and KRAS specific software for PCR analysis and result reporting. The kit contains a Positive Control (PC) and a No Template Control (NTC) which are used to determine the validity of the test.\n\nThe 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",[13],"Device: therascreen® KRAS RGQ PCR Kit",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","therascreen® KRAS RGQ PCR Kit","The investigational device, therascreen® KRAS RGQ PCR Kit, will be used to determine the KRAS G12C mutation status of patients during the screening period of Amgen's clinical trial (20210081)",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Sarah Johnson, Dr.","Qiagen Manchester Limited","STUDY_DIRECTOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","0044 07825866041","sarah.johnson@qiagen.com",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Parul Choudhary","Parul.Choudhary@qiagen.com",[35],{"facility":5,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Manchester","M130BH","United Kingdom","UK",{"type":42,"coordinates":43},"Point",[44,45],-2.23743,53.48095,{"lat":45,"lon":44},[48,51],{"name":49,"role":28,"phone":20,"phoneExt":20,"email":50},"Sarah G Johnson","Sarah.Johnson@qiagen.com",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100565673","dhf-20-1839-2-clinical-performance-study-protocol-for-therascreen-kras-rgq-pcr-kit-100565673",false,"NCT06645236","DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit","Interventional IVD Study Testing DNA From Tumor Tissue Biopsies From mCRC Patients to Determine KRAS G12C Mutation Status for the Inclusion in the Amgen Clinical Trial, 20210081 for the Clinical Performance of Therascreen® KRAS RGQ PCR Kit","Inclusion Criteria:\n\n* Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study.\n\nExclusion Criteria:\n\n* There is no separate inclusion and exclusion criteria for the performance study.","ALL","18 Years",{"count":64,"type":65},600,"ESTIMATED","INTERVENTIONAL",[68],"NA","To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.",[71],"Metastatic Colorectal Cancer (mCRC)",[73,74,75,76,77,78],"Metastatic Colorectal Cancer","therascreen","KRAS G12C","sotorasib","Clinical Performance Study","Companion Diagnostic","2025-08-12",{"date":81,"type":82},"2025-08-15","ACTUAL",{"date":84,"type":82},"2023-12-22",{"date":86,"type":65},"2030-10-31",{"name":5,"class":6},1]