The Registry of Oncology Outcomes Associated With Testing and Treatment
The Registry of Oncology Outcomes Associated With Testing and Treatment
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.
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.
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