Recruitment

Recruitment Status
Not yet recruiting

Inclusion Criteria

Patient is diagnosed with advanced malignancy
Patient or representative provides written informed consent
patient will be willing to have regular follow up visits as part of their standard of care
...
Patient is diagnosed with advanced malignancy
Patient or representative provides written informed consent
patient will be willing to have regular follow up visits as part of their standard of care
Patient is willing to be treated for this malignancy according to a plan determine by them and their physician

Exclusion Criteria

patient is not a candidate or does not desire any treatment for their disease
patient is not a candidate or does not desire any treatment for their disease

Summary

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

Inclusion Criteria

Patient is diagnosed with advanced malignancy
Patient or representative provides written informed consent
patient will be willing to have regular follow up visits as part of their standard of care
...
Patient is diagnosed with advanced malignancy
Patient or representative provides written informed consent
patient will be willing to have regular follow up visits as part of their standard of care
Patient is willing to be treated for this malignancy according to a plan determine by them and their physician

Exclusion Criteria

patient is not a candidate or does not desire any treatment for their disease
patient is not a candidate or does not desire any treatment for their disease

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
  • Study Chair: Razelle Kurzrock, MD Moores Cancer Center at University of California at San Diego 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