The Master Registry of Oncology Outcomes Associated With Testing and Treatment

The Master Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)

Sponsors

Lead Sponsor: Taproot Health

Source 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.

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date October 1, 2031
Primary Completion Date October 1, 2029
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Best overall response (BOR) - 1st line of therapy 1st line of therapy, on average less than 1 year
Best overall response (BOR) - 2nd line of therapy 2nd line of therapy, on average less than 1 year
Best overall response (BOR) - 3rd line of therapy 3rd line of therapy, on average less than 1 year
Best overall response (BOR) - 4th line of therapy 4th line of therapy, on average less than 1 year
Best overall response (BOR) - 5th line of therapy 5th line of therapy, on average less than 1 year
Progression-free survival (PFS) - 1st line of therapy 1st line of therapy, on average less than 1 year
Progression-free survival (PFS) - 2nd line of therapy 2nd line of therapy, on average less than 1 year
Progression-free survival (PFS) - 3rd line of therapy 3rd line of therapy, on average less than 1 year
Progression-free survival (PFS) - 4th line of therapy 4th line of therapy, on average less than 1 year
Progression-free survival (PFS) - 5th line of therapy 5th line of therapy, on average less than 1 year
Secondary Outcome
Measure Time Frame
Overall survival (OS) through study completion, on average less than 3 years
Enrollment 35000
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Biomarker Testing (L)

Description: 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.

Intervention Type: Drug

Intervention Name: Systemic Treatment (T)

Description: 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.

Intervention Type: Other

Intervention Name: Patient Reported Outcomes (P)

Description: Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.

Arm Group Label: Analysis Cohorts

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - patient is not a candidate or does not desire any treatment for their disease

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Judy Taylor

Phone: (801) 396-5190

Email: [email protected]

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Validation Cohoirt

Description: 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.

Label: Analysis Cohorts

Description: 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.

Acronym ROOT
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov