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.
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.
Study Type
OBSERVATIONAL
Enrollment
167
Patients who have received biomarker testing that could affect prognosis or treatment decisions. This generally excludes testing done to assist in the diagnosis of disease or histology where there is no treatment implication from this testing.
Patients who have received any treatment as part of their care. This refers to systemic treatment, but also allows other non-drug related interventions such as surgery or radiotherapy as part of the longitudinal care of the patient.
Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.
Teton Cancer Institute
Idaho Falls, Idaho, United States
Oncology and Hematology of South Texas
Laredo, Texas, United States
Best overall response (BOR) - 1st line of therapy
The best overall response for 1st line of therapy as determined by physician assessment
Time frame: 1st line of therapy, on average less than 1 year
Best overall response (BOR) - 2nd line of therapy
The best overall response for 2nd line of therapy as determined by physician assessment
Time frame: 2nd line of therapy, on average less than 1 year
Best overall response (BOR) - 3rd line of therapy
The best overall response for 3rd line of therapy as determined by physician assessment
Time frame: 3rd line of therapy, on average less than 1 year
Best overall response (BOR) - 4th line of therapy
The best overall response for 4th line of therapy as determined by physician assessment
Time frame: 4th line of therapy, on average less than 1 year
Best overall response (BOR) - 5th line of therapy
The best overall response for 5th line of therapy as determined by physician assessment
Time frame: 5th line of therapy, on average less than 1 year
Progression-free survival (PFS) - 1st line of therapy
The progression free survival for 1st line of therapy as determined by physician assessment
Time frame: 1st line of therapy, on average less than 1 year
Progression-free survival (PFS) - 2nd line of therapy
The progression free survival for 2nd line of therapy as determined by physician assessment
Time frame: 2nd line of therapy, on average less than 1 year
Progression-free survival (PFS) - 3rd line of therapy
The progression free survival for 3rd line of therapy as determined by physician assessment
Time frame: 3rd line of therapy, on average less than 1 year
Progression-free survival (PFS) - 4th line of therapy
The progression free survival for 4th line of therapy as determined by physician assessment
Time frame: 4th line of therapy, on average less than 1 year
Progression-free survival (PFS) - 5th line of therapy
The progression free survival for 5th line of therapy as determined by physician assessment
Time frame: 5th line of therapy, on average less than 1 year
Overall survival (OS)
The overall survival of a patient from the time of being diagnosed with advanced disease until death
Time frame: through study completion, on average less than 3 years
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