A solid tumor/cancer is an abnormal tissue mass that arises from uncontrolled growth of cells and continues to grow locally or spread to other parts of the body (metastatic). A solid tumor/cancer is an abnormal tissue mass that arises from uncontrolled growth of cells and continues to grow locally or spread to other parts of the body (metastatic).
Conditions
Interventions
F1CDx assay
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The performance study aims to enrol patients =18 years of age with measurable disease according to RECIST v1.1 assessed by the investigator. Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 and confirmed presence of the RAS mutation(s) (defined as patients with nonsynonymous mutation at RAS codon 12, 13, 61) as documented with a prior testing report of a blood or tumour tissue sample, or through central laboratory testing of a representative tumour tissue sample collected during screening phase.The performance study will include subjects pre-screened and screened with F1CDx. F1CDx will be used to test approximately 300 patients to determine RAS mutation status, and, therefore, patient eligibility for participation in clinical trial YO45758. One formalin-fixed, paraffin embedded (FFPE) tumour specimen per patient will be needed for each F1CDx test. Certain patients with prior FMI testing may be enrolled utilizing sequencing data from their previously tested specimen instead of testing a new tissue specimen.Only patients with solid tumours that harbour RAS mutations detected by prospective F1CDx testing are included in this CPS. A recent archival tumour tissue specimen, preferably collected within 3 years or freshly collected FFPE sample will be collected at screening from all participants to confirm the RAS mutation status with central testing for participants without prior confirmed RAS mutation status.Inclusion criteria for subjects providing specimens: Patients with solid tumours that harbour RAS mutations detected by prospective F1CDx testing are included in this CPS. A representative FFPE tumour specimen in a paraffin block (preferred) or at least 11 slides containing unstained, freshly cut, serial sections (4-5 microns thick) must be submitted for F1CDx confirmatory testing.The following requirements must be met for the sample to pass the Foundation Medicine pathology review for processing with the F1CDx:Optimal tissue volume of at least 0.6 mm3 or absolute minimum tissue volume of 0.2 mm3.Final percent tumour nuclei of at least 20% (optimally 30% or greater).Sufficient cellularity – determined by Foundation Medicine pathologist discretion.Tumour tissue should be of good quality, as determined on the basis of total and viable tumor content and volume (i.e., preserved cellular context and tissue architecture). Samples collected via resection, core-needle biopsy, embedded in a single paraffin block), or excisional, incisional, punch, or forceps biopsy are acceptable. 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&nb
Exclusion criteria
Exclusion criteria: Exclusion criteria for subjects providing specimens: Patients without biomarkers of interests as detected by the enrolment assays in the YO45758 study.A recent archival tumour tissue specimen, preferably collected within 3 years or freshly collected FFPE sample will be collected at screening from all participants to confirm the RAS mutation status with central testing. Tumour samples after the completion of the last anti-cancer therapy is preferred.Additional details on the inclusion and exclusion criteria of the study subjects are described in Sections 5.2 and 5.3 of the clinical trial protocol for YO45758.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To support the clinical validation of F1CDx for detection of RAS mutations in patients with solid tumours, this performance study will conduct a concordance analysis between the F1CDx and local test results. Positive percent agreement (PPA) will be used as the endpoint for this performance study to estimate the concordance of positive biomarker status between local testing and F1CDx in identifying patients with solid tumours harbouring RAS mutations.In addition, selected clinical outcomes derived from clinical trial YO45758 will be summarized descriptively as part of exploratory analysis. These exploratory analyses will use variables derived under the clinical study protocol and the SAP and will not be used to establish clinical efficacy of the investigational medicinal product or clinical utility of the device. | — |
Countries
Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom
Contacts
Public ContactF F. Hoffmann-La Roche
Hoffmann-La Roche
Outcome results
None listed