High-grade sarcoma Cancer
Conditions
Interventions
This study will be a single-centre observational cohort study, with an internal blinded comparison where each patient acts as their own control. The study will involve the systematic and prospective c
Sponsors
Roche (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For study participants: 1. Adult male or female aged 18 years and above 2. Diagnosis of high-grade sarcoma (Grade 2/3) on either a diagnostic or surgical sample confirmed by the Oxford sarcoma MDT 3. Participant able to undergo all clinical treatments and follow-up coordinated by the Oxford Sarcoma supra-regional MDT 4. Willing and able to provide signed informed consent for OxPOS-NAVIFY®, including for additional blood sampling FMI and other genomic analysis, and collection of clinical data 5. Able to complete questionnaires for participant-reported outcomes 6. Life expectancy greater than 12 weeks from diagnosis For MDT participants: 1. Member of the standard of care Oxford Sarcoma MDT of OXPOS MDT 2. Clinician involved in sarcoma care decision making 3. Willing and able to provide signed informed consent
Exclusion criteria
Exclusion criteria: For study participants: 1. Age less than 18 years 2. Sarcoma managed by another hospital or sarcoma MDT 3. Exclusion from biopsies if there is a known contraindication, such as a hypersensitivity to CT contrast media For MDT participants: 1. Conflict of interest with the OxPOS study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with high-grade sarcoma who have additional pathway options as a result of the OxPOS-NAVIFY® MDT analysis compared to standard of care, measured from the time of the standard sarcoma MDT decision to the study completion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number and type of either diagnostic or actionable genomic variants identified using a Foundation Medicine panel and extended genomic sequencing platforms at the initial diagnostic timepoint 2. Longitudinal outcome of tumour growth rate evaluation (delta-radiomics), including heterogeneity analysis integrated with genomics, at the diagnostic timepoint to the study completion 3. Number and types of germline findings using an extended validated variant panel at the diagnostic timepoint 4. Approved ISO/IEC 9126-4 metrics of effectiveness, efficiency and satisfaction related to OxPOS-NAVIFY® workflow at the diagnostic and the beginning of each standard of care treatment intervention timepoints, to the study completion 5. Longitudinal analysis of cognitive burden and confidence of decision-making of clinicians using CSQU and NASA task load questionnaires and semi-structured interviews up to six timepoints spaced between 3-36 months after the diagnostic timepoint 6. Longitudinal analysis of the patient-reported psychological impact and quality of life measured using HADS score and EORTC-QLQ-C30 at the diagnostic, prior to and 3-6 months after the OxPOS clinic 7. Overall survival and progression-free survival analysed by Kaplan–Meier survival and measured from patient records from the diagnostic timepoint 8. Supervised machine learning classifiers for diagnostic groups and treatment responders e.g. in relation to overall survival, progression-free survival, and quality of life from the diagnostic timepoint to the completion of the study 9. Cost-effectiveness analysis and causal inference based on cost per event measured using NHS costings relative to the additional pathway options resulting from the OxPOS-NAVIFY® MDT analysis, from the diagnostic timepoint to the completion of the study | — |
Countries
England, United Kingdom
Outcome results
None listed