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

November 20, 2023 updated by: Taproot Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Teton Cancer Institute
        • Contact:
        • Contact:
          • Jeffery Hancock, MD
          • Phone Number: 208-356-9559
        • Principal Investigator:
          • Jeffery Hancock, MD
    • Texas
      • Laredo, Texas, United States, 78041
        • Recruiting
        • Oncology and Hematology of South Texas
        • Contact:
        • Principal Investigator:
          • Eduardo Miranda, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patient with advanced cancer is eligible for inclusion in this study. Sponsor may identity specific subsets of patients that have a specific characteristic, received a certain type of testing or treatment, or are followed for a certain time period as part of their standard of care independent of this study. These identified areas will never exclude any gender, race, or socioeconomic status.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Validation Cohort
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.
Diagnostic test: Biomarker Testing (L)
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
Drug: Systemic Treatment (T)
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:
  • Chemotherapy
  • Biologic therapy
  • Targeted therapy
  • Immunotherapy
Analysis Cohorts
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.
Diagnostic test: Biomarker Testing (L)
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
Drug: Systemic Treatment (T)
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:
  • Chemotherapy
  • Biologic therapy
  • Targeted therapy
  • Immunotherapy
Other: Patient Reported Outcomes (P)
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
Retrospective Chart Review Cohorts
This arm will use retrospective data obtained through systematic chart review on previously seen patients to compare, contrast, or enhance the efforts of the prospective arms. Because most RWD has been traditionally obtained through retrospective methods, this is also considered the "control arm." Data in this arm will be collected without any patient identifiers. This arm is optional.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response (BOR) - 1st line of therapy
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
1st line of therapy, on average less than 1 year
Best overall response (BOR) - 2nd line of therapy
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
2nd line of therapy, on average less than 1 year
Best overall response (BOR) - 3rd line of therapy
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
3rd line of therapy, on average less than 1 year
Best overall response (BOR) - 4th line of therapy
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
4th line of therapy, on average less than 1 year
Best overall response (BOR) - 5th line of therapy
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
5th line of therapy, on average less than 1 year
Progression-free survival (PFS) - 1st line of therapy
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
1st line of therapy, on average less than 1 year
Progression-free survival (PFS) - 2nd line of therapy
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
2nd line of therapy, on average less than 1 year
Progression-free survival (PFS) - 3rd line of therapy
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
3rd line of therapy, on average less than 1 year
Progression-free survival (PFS) - 4th line of therapy
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
4th line of therapy, on average less than 1 year
Progression-free survival (PFS) - 5th line of therapy
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
5th line of therapy, on average less than 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
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
through study completion, on average less than 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taproot Health

Investigators

  • Study Chair: Razelle Kurzrock, MD, Moores Cancer Center at University of California at San Diego
  • Principal Investigator: Raymond Bergan, MD, OHSU Knight Cancer Institute
  • Principal Investigator: Vivek Subbiah, MD, M.D. Anderson Cancer Center
  • Principal Investigator: Jennifer Johnson, MD, PhD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will likely be shared, but will be determined by participating clinical sites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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