Clinical trial NCT04028479: The Registry of Oncology Outcomes Associated with Testing and Treatment
Official title: The Registry of Oncology Outcomes Associated with Testing and Treatment (ROOT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma
Adenocystic Carcinoma
Anal Cancer
Appendix Cancer
Brain Tumor
Glioblastoma
Astrocytoma
Bile Duct Cancer
Cholangiocarcinoma
Bladder Cancer
Bone Cancer
Synovial Sarcoma
Chondrosarcoma
Liposarcoma
Sarcoma, Kaposi
Sarcoma,Soft Tissue
Sarcoma
Osteosarcoma
CNS Cancer
Brain Stem Neoplasms
Breast Cancer
Cervical Cancer
Colorectal Cancer
Rectal Cancer
Colon Cancer
Esophageal Cancer
Esophagus Cancer
Cancer of Colon
Pancreatic Cancer
Cancer of Pancreas
Testis Cancer
Testicular Cancer
Ureter Cancer
Renal Cell Carcinoma
Kidney Cancer
Gestational Trophoblastic Tumor
Head and Neck Neoplasms
Parotid Tumor
Larynx Cancer
Tongue Cancer
Pharynx Cancer
Salivary Gland Cancer
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Multiple Myeloma
Non Hodgkin Lymphoma
Carcinoid Tumor
Lung Cancer
Neuroendocrine Tumors
Mesothelioma
Thyroid Cancer
Parathyroid Neoplasms
Adrenal Cancer
Small Bowel Cancer
Stomach Cancer
Liver Cancer
Hepatic Cancer
Melanoma
Skin Cancer
Unknown Primary Tumors
Uterine Cancer
Fallopian Tube Cancer
Ovarian Cancer
Prostate Cancer
Vaginal Cancer
Penile Cancer
Vulvar Cancer
Waldenstrom Macroglobulinemia
Cancer, Advanced
Thymus Cancer
Nasopharyngeal Carcinoma
Multiple Endocrine Neoplasia
Pheochromocytoma
Small Cell Carcinoma
Pulmonary Carcinoma
Keywords: Precision Medicine
Molecular Sequence Data
Databases, Genetic
High-Throughput Nucleotide Sequencing
Massively-Parallel Sequencing
Observational Study
Treatment
Patient Outcome Assessment
Adaptive clinical trial
Molecular Typing
Response Rate
Progression Free Survival
Overall Survival
Lead sponsor: Taproot Health
Sponsor class: INDUSTRY
First posted: 2019-07-22
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with advanced cancer is eligible for inclusion in this study. Sponsor may identity specific subsets of patients that have a specific characteristic, received a certain type of testing or treatment, or are followed for a certain time period as part of their standard of care independent of this study. These identified areas will never exclude any gender, race, or socioeconomic status.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Best overall response (BOR) - 1st line of therapy
timeFrame: 1st line of therapy, on average less than 1 year
measure: Best overall response (BOR) - 2nd line of therapy
timeFrame: 2nd line of therapy, on average less than 1 year
measure: Best overall response (BOR) - 3rd line of therapy
timeFrame: 3rd line of therapy, on average less than 1 year
measure: Best overall response (BOR) - 4th line of therapy
timeFrame: 4th line of therapy, on average less than 1 year
measure: Best overall response (BOR) - 5th line of therapy
timeFrame: 5th line of therapy, on average less than 1 year
measure: Progression-free survival (PFS) - 1st line of therapy
timeFrame: 1st line of therapy, on average less than 1 year
measure: Progression-free survival (PFS) - 2nd line of therapy
timeFrame: 2nd line of therapy, on average less than 1 year
measure: Progression-free survival (PFS) - 3rd line of therapy
timeFrame: 3rd line of therapy, on average less than 1 year
measure: Progression-free survival (PFS) - 4th line of therapy
timeFrame: 4th line of therapy, on average less than 1 year
measure: Progression-free survival (PFS) - 5th line of therapy
timeFrame: 5th line of therapy, on average less than 1 year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: through study completion, on average less than 3 years
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Teton Cancer Institute
state: Idaho
city: Laredo
country: United States
facility: Oncology and Hematology of South Texas
state: Texas
Study officials:
affiliation: Moores Cancer Center at University of California at San Diego
name: Razelle Kurzrock, MD
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Vivek Subbiah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Jennifer Johnson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: OHSU Knight Cancer Institute
name: Raymond Bergan, MD
role: PRINCIPAL_INVESTIGATOR
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