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

Taproot Health

Status: Enrolling

Conditions: Testicular Cancer; Osteosarcoma; Glioblastoma; Uterine Cancer; Chondrosarcoma; Ureter Cancer; Colon Cancer; Adenocystic Carcinoma; Cholangiocarcinoma; Fallopian Tube Cancer; Non Hodgkin Lymphoma; Adenocarcinoma; Sarcoma,Soft Tissue; Liver Cancer; Small Bowel Cancer; Bladder Cancer; Pulmonary Carcinoma; Skin Cancer; Multiple Endocrine Neoplasia; Acute Lymphoblastic Leukemia; Synovial Sarcoma; Acute Myeloid Leukemia; Breast Cancer; Hepatic Cancer; Penile Cancer; Appendix Cancer; Gestational Trophoblastic Tumor; Sarcoma, Kaposi; Lung Cancer; Parotid Tumor; Ovarian Cancer; Tongue Cancer; Liposarcoma; Bone Cancer; Thymus Cancer; Multiple Myeloma; Vulvar Cancer; Astrocytoma; Nasopharyngeal Carcinoma; Chronic Myeloid Leukemia; Carcinoid Tumor; Prostate Cancer; Stomach Cancer; Brain Stem Neoplasms; Pheochromocytoma; Waldenstrom Macroglobulinemia; Anal Cancer; Cancer of Colon; Melanoma; Esophageal Cancer; Vaginal Cancer; Head and Neck Neoplasms; Testis Cancer; Cancer of Pancreas; Sarcoma; Unknown Primary Tumors; Small Cell Carcinoma; Thyroid Cancer; CNS Cancer; Parathyroid Neoplasms; Renal Cell Carcinoma; Cancer, Advanced; Pancreatic Cancer; Esophagus Cancer; Salivary Gland Cancer; Brain Tumor; Neuroendocrine Tumors; Bile Duct Cancer; Pharynx Cancer; Kidney Cancer; Adrenal Cancer; Mesothelioma; Larynx Cancer; Cervical Cancer; Rectal Cancer; Colorectal Cancer

Treatments: Drug: Systemic Treatment (T); Diagnostic Test: Biomarker Testing (L); Other: Patient Reported Outcomes (P)

Study type: Observational

Funder types: Industry

Identifiers

NCT04028479

ROOT

Details and patient eligibility

About

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.

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.

Enrollment: 100,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100,000 participants in 3 patient groups

Validation Cohort

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.

Treatment:

Diagnostic Test: Biomarker Testing (L)

Drug: Systemic Treatment (T)

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.

Treatment:

Other: Patient Reported Outcomes (P)

Diagnostic Test: Biomarker Testing (L)

Drug: Systemic Treatment (T)

Retrospective Chart Review Cohorts

Description:

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.