Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Adenocarcinoma, Adenocystic Carcinoma, Adrenal Cancer, Anal Cancer, Appendix Cancer, Astrocytoma, Bile Duct Cancer, Bladder Cancer, Bone Cancer, Brain Stem Neoplasms, Brain Tumor, Breast Cancer, Cancer, Advanced, Cancer of Colon, Cancer of Pancreas, Carcinoid Tumor, Cervical Cancer, Cholangiocarcinoma, Chondrosarcoma, Chronic Myeloid Leukemia, CNS Cancer, Colon Cancer, Colorectal Cancer, Esophageal Cancer, Esophagus Cancer, Fallopian Tube Cancer, Gestational Trophoblastic Tumor, Glioblastoma, Head and Neck Neoplasms, Hepatic Cancer, Kidney Cancer, Larynx Cancer, Liposarcoma, Liver Cancer, Lung Cancer, Melanoma, Mesothelioma, Multiple Endocrine Neoplasia, Multiple Myeloma, Nasopharyngeal Carcinoma, Neuroendocrine Tumors, Non Hodgkin Lymphoma, Osteosarcoma, Ovarian Cancer, Pancreatic Cancer, Parathyroid Neoplasms, Parotid Tumor, Penile Cancer, Pharynx Cancer, Pheochromocytoma, Prostate Cancer, Pulmonary Carcinoma, Rectal Cancer, Renal Cell Carcinoma, Salivary Gland Cancer, Sarcoma, Sarcoma, Kaposi, Sarcoma,Soft Tissue, Skin Cancer, Small Bowel Cancer, Small Cell Carcinoma, Stomach Cancer, Synovial Sarcoma, Testicular Cancer, Testis Cancer, Thymus Cancer, Thyroid Cancer, Tongue Cancer, Unknown Primary Tumors, Ureter Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer, Waldenstrom Macroglobulinemia
Conditions
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
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.
Interventions
Patients who have received biomarker testing that could affect prognosis or treatment decisions. This generally excludes testing done to assist in the diagnosis of disease or histology where there is no treatment implication from this testing.
Patients who have received any treatment as part of their care. This refers to systemic treatment, but also allows other non-drug related interventions such as surgery or radiotherapy as part of the longitudinal care of the patient.
Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) - 5th line of therapy | 5th line of therapy, on average less than 1 year | The progression free survival for 5th line of therapy as determined by physician assessment |
| Best overall response (BOR) - 1st line of therapy | 1st line of therapy, on average less than 1 year | The best overall response for 1st line of therapy as determined by physician assessment |
| Best overall response (BOR) - 2nd line of therapy | 2nd line of therapy, on average less than 1 year | The best overall response for 2nd line of therapy as determined by physician assessment |
| Best overall response (BOR) - 3rd line of therapy | 3rd line of therapy, on average less than 1 year | The best overall response for 3rd line of therapy as determined by physician assessment |
| Best overall response (BOR) - 4th line of therapy | 4th line of therapy, on average less than 1 year | The best overall response for 4th line of therapy as determined by physician assessment |
| Best overall response (BOR) - 5th line of therapy | 5th line of therapy, on average less than 1 year | The best overall response for 5th line of therapy as determined by physician assessment |
| Progression-free survival (PFS) - 1st line of therapy | 1st line of therapy, on average less than 1 year | The progression free survival for 1st line of therapy as determined by physician assessment |
| Progression-free survival (PFS) - 2nd line of therapy | 2nd line of therapy, on average less than 1 year | The progression free survival for 2nd line of therapy as determined by physician assessment |
| Progression-free survival (PFS) - 3rd line of therapy | 3rd line of therapy, on average less than 1 year | The progression free survival for 3rd line of therapy as determined by physician assessment |
| Progression-free survival (PFS) - 4th line of therapy | 4th line of therapy, on average less than 1 year | The progression free survival for 4th line of therapy as determined by physician assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | through study completion, on average less than 3 years | The overall survival of a patient from the time of being diagnosed with advanced disease until death |
Countries
United States