Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

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

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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) ...

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.

Tracking Information

NCT #
NCT04028479
Collaborators
Not Provided
Investigators
Study Chair: Razelle Kurzrock, MD Moores Cancer Center at University of California at San Diego Principal Investigator: Vivek Subbiah, MD M.D. Anderson Cancer Center Principal Investigator: Jennifer Johnson, MD, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University Principal Investigator: Raymond Bergan, MD OHSU Knight Cancer Institute