Personalised Immunotherapy Platform
NCT Number: NCT06536257
Acronym: PIP-PREDICT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Melanoma|Cutaneous Squamous Cell Carcinoma|Basal Cell Carcinoma|Merkel Cell Carcinoma|Solid Tumor
Interventions: OTHER: Predictive model
Sponsor: Melanoma Institute Australia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-08
Completion Date: 2037-06-01
Locations: Chris O'Brien Lifehouse, Sydney, New South Wales, 2050, Australia|Melanoma Institute Australia, Sydney, New South Wales, 2065, Australia|Westmead Hospital, Sydney, New South Wales, 2145, Australia

Summary:
This is a non-interventional study to prospectively test a suite of predictive biomarker models of immunotherapy resistance in patients with melanoma, non-melanoma skin cancers and other solid tumours. The study will evaluate the documentation, processes, accuracy and utility of the predictive biomarker model in clinical practice.

Primary Outcome Measures: Assessment of the accuracy of predictive test results in melanoma, Proportion of correctly predicted responders and non-responders to the immunotherapy treatment decision by the MDT, based on the 6 month progression-free survival (PFS), 6 months
Secondary Outcome Measures: Assessment of the inaccuracy of predictive test results, Identification of patient populations for which the predictive model did not predict response (6 month PFS) to immunotherapy, 6 months|Evaluation of a test request form - completion rate, Proportion of required data completed by the referring clinician, 2 years|Analysis of potential barriers to complete a test request form, Identification of barriers to completion of the request form, 2 years|Evaluation of accessible data in medical records for completion of a test request form, Proportion of required data that is readily available in routine patient medical records, 2 years|Evaluation of a test request form from clinician feedback via qualitative surveys, Summarised feedback from clinicians in narrative format, 2 years|Conduct qualitative surveys to evaluate a test result report from consumers' viewpoint, Survey results from consumer responses on the comprehension of risk probability (mean score from a 7 point scale), communication efficacy (mean score from a 4 point scale), significance and actionability (mean score from a 7 point scale) of the information within the report, 1 year|Qualiaitive evaluation of a test result report from consumers' viewpoint, Interviewer notes and transcriptions of consumers' answers to structured interview questions coded in software for qualitative data to identify and evaluate the most significant problems, highlight cases of poor comprehension, and assess the degree to which the reports met consumers' information needs, 1 year|Conduct qualitative surveys to evaluation of a test result report from the clinicians' viewpoint, Survey results from clinicians on the utility (mean score from a 7 point scale) and comprehension (mean score from a 7 point scale) of the report, 2 years|Qualiaitive evaluation of a test result report from clinicians' viewpoint, Summarised feedback from clinicians to structured interview questions, 2 years|Evaluation of the predictive model workflow on result completion, Identification of workflow barriers from request form to result delivery, 2 years|Evaluation of the predictive model workflow on result delivery, Time from request form submission to predictive test result delivery (business days), 2 years|Evaluation of the predictive model workflow turnaround timeframes, Proportion of test results received within 2 weeks (10 business days) from request, 2 years|Evaluation of the predictive model workflow delays, Summary of reasons for delay in providing test result, 2 years|Evaluation of the predictive model workflow processes, Identification of processes that require change (if required), the number of identified issues found and the result of implemented changes., 2 years|Availability of suitable tissue for the predictive model testing protocol, Proportion of patients who could not be tested because no suitable tissue available (and reasons why)., 2 years|Data quality for the predictive model testing protocol, Proportion of patients who could not be tested because of missing clinical data (and which data and why missing), 2 years|A cost analysis of the predictive model testing protocol, Calculation of the cost per individual test (to include staff time, reagents, proportionate use of analytical equipment, assay costs, pathology service fee for sample preparation and shipping), 2 years|Evaluation of the predictive test report in shaping clinician treatment decision making, Index of the quality of team decision making using the multidisciplinary team (MDT) metric of decision making (MODe) framework, 1 year|Evaluation of the impact of predictive test result in shaping clinician treatment decision making, Decision making with and without the knowledge of the predictive test report (Decision Impact Analysis) by the MDT, 2 years|Concordance of clinician treatment decision making with predictive test results, Concordance of treatment recommendation(s) before and after provision of the predictive test report per patient case, 2 years|Discordance of clinician treatment decision making with predictive test results, For treatment choice discordance, proportion of theoretical decisions based on the report that would be adhered to, 2 years|Exploratory evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples, Identification of biomarkers in blood and/or stools predictive of response or resistance to immunotherapy that can be incorporated into the predictive model, 5 years|Evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples on the accuracy of the predictive model, Impact of the inclusion of blood and/or stool biomarkers to the accuracy of the predictive model on predicting response to immunotherapy at 6 months post-treatment, 5 years|Assessment of the accuracy of predictive test results in non-melanoma skin cancer and non-melanoma tumours, Proportion of correctly predicted responders and non-responders to immunotherapy treatment based on the 6 month progression-free survival, 6 months