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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms

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

NCT number NCT04028479
Study type Observational [Patient Registry]
Source Taproot Health
Contact Lori Miles
Phone (801) 396-5190
Email lori.miles@taprootco.com
Status Recruiting
Phase
Start date May 5, 2021
Completion date October 1, 2031

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