Advanced FIGO Stage III‐IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer
Conditions
Brief summary
Percentage of HR status agreement between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution. The corresponding 95% confidence intervals (CI) will be reported.
Detailed description
Sensitivity, specificity, predictive positive and negative value of the VHIO-CARD-300 test, using SOPHiA DDM™ Dx HRD Solution as a reference test., Progression free survival (PFS) and overall survival (OS) will be analysed in HRD and HRP groups, as determined by the VHIOCARD- 300 test. PFS: time from the date of enrolment to the date of first documentation of disease progression or death due to any cause, whichever occurs first. OS: time from the date of enrolment to the date of death due to any cause. The progression of disease will be assessed by the Investigator according to the modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) will be used., PFS and OS will be analysed in discrepant cases (i.e., HRD positive by VHIO-CARD- 300 test but HRD negative by SOPHiA DDM™ Dx HRD Solution and HRD negative by VHIO-CARD-300 test but HRD positive by SOPHiA DDM™ Dx HRD Solution)., Percentage of inconclusive results will be estimated for each test, Assessment of adverse events (AEs) graded by the National Cancer Institute (NCI) CTCAE v5.0, serious adverse events (SAEs), abnormal vital signs, abnormal ECG results, and evaluation of laboratory parameters.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of HR status agreement between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution. The corresponding 95% confidence intervals (CI) will be reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, predictive positive and negative value of the VHIO-CARD-300 test, using SOPHiA DDM™ Dx HRD Solution as a reference test., Progression free survival (PFS) and overall survival (OS) will be analysed in HRD and HRP groups, as determined by the VHIOCARD- 300 test. PFS: time from the date of enrolment to the date of first documentation of disease progression or death due to any cause, whichever occurs first. OS: time from the date of enrolment to the date of death due to any cause. The progression of disease will be assessed by the Investigator according to the modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) will be used., PFS and OS will be analysed in discrepant cases (i.e., HRD positive by VHIO-CARD- 300 test but HRD negative by SOPHiA DDM™ Dx HRD Solution and HRD negative by VHIO-CARD-300 test but HRD positive by SOPHiA DDM™ Dx HRD Solution)., Percentage of inconclusive results will be estimated for each test, Assessment of adverse events (A | — |
Countries
Spain