The Registry of Oncology Outcomes Associated with Testing and Treatment
- Conditions
- Appendix CancerBladder CancerOsteosarcomaCNS CancerBrain TumorGlioblastomaBone CancerSynovial SarcomaSarcomaBreast Cancer
- Interventions
- Diagnostic Test: Biomarker Testing (L)Drug: Systemic Treatment (T)Other: Patient Reported Outcomes (P)
- Registration Number
- NCT04028479
- Lead Sponsor
- Taproot Health
- Brief Summary
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
- Detailed Description
This is a master observational trial (MOT). Anyone who has been diagnosed with advanced cancer is eligible as long as they are a candidate for treatment. Each patient will receive testing and treatment as determined by patient in consultation with physician. ROOT will proceed in two directions: (1) Validation Cohorts. These patients will demonstrate the ability of the MOT to prospectively collect data using the same protocol and related documents, standardized data elements and processes, and accepted scientific endpoints; and (2) Analysis Cohorts. The modular nature of the study allows collection of RWD ranging from diagnosis only to the full treatment course of the of the patient. Patients are grouped to allow focused data collection or a specific analysis. Analysis cohorts can be created from patients already enrolled in ROOT or be defined prospectively. Because of the ongoing advancements of molecular based oncology, this trial allows a detailed focus on molecular testing as part of any cohort.
Data is reported by the group that is most qualified to provide this information and is proved, at point of care, using standardized data elements and processes. Physicians will report diagnosis, molecular characteristics, staging, disease burden, significant comorbidities, treatment response, and medical decision making. Molecular testing (reports and details) will be requested from testing laboratories. Any diagnostic films will be received digitally from the location the study was performed. Research staff assist in data entry and providing physicians needed data as part of the regular workflow to allow point-of-care reporting.
The Validation Cohorts and Analysis Cohorts may run sequentially or in parallel with each other.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- Patient or representative provides written informed consent
- Patient is diagnosed with advanced malignancy
- Patient is willing to be treated for this malignancy according to a plan determine by them and their physician
- patient will be willing to have regular follow up visits as part of their standard of care
- patient is not a candidate or does not desire any treatment for their disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Validation Cohort Biomarker Testing (L) Patients enrolled into the study to allow validation of a specific element, process, or endpoint. Validation will be done showing concordance with traditional interventional trial standards. Validation Cohort Systemic Treatment (T) Patients enrolled into the study to allow validation of a specific element, process, or endpoint. Validation will be done showing concordance with traditional interventional trial standards. Analysis Cohorts Biomarker Testing (L) Patient who are enrolled into the study to allow analysis to determine any association, effect, or benefit. Cohorts can be determined prospectively and/or retrospectively for data already collected, Cohorts are identified to highlight collection of information on patients who are already receiving any treatment or testing as determined by the physician and patient independent of this study. Because many analysis cohorts will be determined in patients already enrolled in the study, this group is inclusive of many different sub-groupings or specific analysis cohorts of patients. Analysis Cohorts Patient Reported Outcomes (P) Patient who are enrolled into the study to allow analysis to determine any association, effect, or benefit. Cohorts can be determined prospectively and/or retrospectively for data already collected, Cohorts are identified to highlight collection of information on patients who are already receiving any treatment or testing as determined by the physician and patient independent of this study. Because many analysis cohorts will be determined in patients already enrolled in the study, this group is inclusive of many different sub-groupings or specific analysis cohorts of patients. Analysis Cohorts Systemic Treatment (T) Patient who are enrolled into the study to allow analysis to determine any association, effect, or benefit. Cohorts can be determined prospectively and/or retrospectively for data already collected, Cohorts are identified to highlight collection of information on patients who are already receiving any treatment or testing as determined by the physician and patient independent of this study. Because many analysis cohorts will be determined in patients already enrolled in the study, this group is inclusive of many different sub-groupings or specific analysis cohorts of patients.
- Primary Outcome Measures
Name Time Method Best overall response (BOR) - 3rd line of therapy 3rd line of therapy, on average less than 1 year The best overall response for 3rd line of therapy as determined by physician assessment
Best overall response (BOR) - 1st line of therapy 1st line of therapy, on average less than 1 year The best overall response for 1st line of therapy as determined by physician assessment
Progression-free survival (PFS) - 2nd line of therapy 2nd line of therapy, on average less than 1 year The progression free survival for 2nd line of therapy as determined by physician assessment
Best overall response (BOR) - 2nd line of therapy 2nd line of therapy, on average less than 1 year The best overall response for 2nd line of therapy as determined by physician assessment
Best overall response (BOR) - 4th line of therapy 4th line of therapy, on average less than 1 year The best overall response for 4th line of therapy as determined by physician assessment
Progression-free survival (PFS) - 3rd line of therapy 3rd line of therapy, on average less than 1 year The progression free survival for 3rd line of therapy as determined by physician assessment
Progression-free survival (PFS) - 5th line of therapy 5th line of therapy, on average less than 1 year The progression free survival for 5th line of therapy as determined by physician assessment
Best overall response (BOR) - 5th line of therapy 5th line of therapy, on average less than 1 year The best overall response for 5th line of therapy as determined by physician assessment
Progression-free survival (PFS) - 1st line of therapy 1st line of therapy, on average less than 1 year The progression free survival for 1st line of therapy as determined by physician assessment
Progression-free survival (PFS) - 4th line of therapy 4th line of therapy, on average less than 1 year The progression free survival for 4th line of therapy as determined by physician assessment
- Secondary Outcome Measures
Name Time Method Overall survival (OS) through study completion, on average less than 3 years The overall survival of a patient from the time of being diagnosed with advanced disease until death
Trial Locations
- Locations (2)
Teton Cancer Institute
🇺🇸Idaho Falls, Idaho, United States
Oncology and Hematology of South Texas
🇺🇸Laredo, Texas, United States