NCT Number: NCT04028479
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.
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Notify Me18 year and older
All sexes
Observational
Teton Cancer Institute, Idaho Falls, Idaho, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Biomarker Testing, Molecular Testing, Next-generation sequencing (NGS), Multiplex molecular 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.
Other names: Biologic therapy, Targeted therapy, Immunotherapy, Chemotherapy
Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.
Other names: Patient experience, Quality of life, Self-reporting
Time frame: 1st line of therapy, on average less than 1 year
The best overall response for 1st line of therapy as determined by physician assessment
Time frame: 2nd line of therapy, on average less than 1 year
The best overall response for 2nd line of therapy as determined by physician assessment
Time frame: 3rd line of therapy, on average less than 1 year
The best overall response for 3rd line of therapy as determined by physician assessment
Time frame: 4th line of therapy, on average less than 1 year
The best overall response for 4th line of therapy as determined by physician assessment
Time frame: 5th line of therapy, on average less than 1 year
The best overall response for 5th line of therapy as determined by physician assessment
Time frame: 1st line of therapy, on average less than 1 year
The progression free survival for 1st line of therapy as determined by physician assessment
Time frame: 2nd line of therapy, on average less than 1 year
The progression free survival for 2nd line of therapy as determined by physician assessment
Time frame: 3rd line of therapy, on average less than 1 year
The progression free survival for 3rd line of therapy as determined by physician assessment
Time frame: 4th line of therapy, on average less than 1 year
The progression free survival for 4th line of therapy as determined by physician assessment
Time frame: 5th line of therapy, on average less than 1 year
The progression free survival for 5th line of therapy as determined by physician assessment
Time frame: 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
Taproot Health
Industry
The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
Acronym: ROOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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