Clinical trialObsCompleted
The Registry of Oncology Outcomes Associated With Testing and Treatment
The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
- Outcome
- Finished, no results posted
- Phase
- Obs
- Status
- Completed
- Study type
- Observational
- Start
- 5 May 2021
- Expected end
- 31 October 2024
- Enrollment
- 167 participants
- Sites
- 2
- Primary outcomes
- Best overall response (BOR) - 1st line of therapy; Best overall response (BOR) - 2nd line of therapy; Best overall response (BOR) - 3rd line of therapy; Best overall response (BOR) - 4th line of therapy; Best overall response (BOR) - 5th line of therapy
- Sponsor
- Industry
- Results posted
- No
- Last update
- 18 December 2024
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.