Breast Cancer Clinical Trial

The Registry of Oncology Outcomes Associated With Testing and Treatment

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

100000

Study ID:

NCT04028479

Recruitment Status:

Recruiting

Sponsor:

Taproot Health

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There are 2 Locations for this study

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Teton Cancer Institute
Idaho Falls Idaho, 83404, United States More Info
Manager of Oncology Services
Contact
208-356-9559
[email protected]
Jeffery Hancock, MD
Contact
208-356-9559
Jeffery Hancock, MD
Principal Investigator
Oncology and Hematology of South Texas
Laredo Texas, 78041, United States More Info
Cesar Flores
Contact
872-222-7830
[email protected]
Eduardo Miranda, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

100000

Study ID:

NCT04028479

Recruitment Status:

Recruiting

Sponsor:


Taproot Health

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