The Registry of Oncology Outcomes Associated With Testing and Treatment

  • STATUS
    Recruiting
  • End date
    Oct 1, 2031
  • participants needed
    100000
  • sponsor
    Taproot Health
Updated on 22 October 2021
primary cancer
diagnostic procedures
lab tests

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.

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.

Details
Condition Colon Cancer, Acute myeloid leukemia, Colon cancer; rectal cancer, Rectal Disorders, anll, Brain Tumor, Neuroectodermal Tumor, Biliary neoplasm, Carcinoid Tumor, Colorectal Cancer, Rectal Cancer, acute myeloblastic leukemia, liposarcoma, Breast Cancer Diagnosis, Thyroid Disease, Pain; Bone Neoplasms; Neoplasm Metastasis, Brain Metastases, PARATHYROID DISORDER, Thymoma, neuroendocrine tumors, Pulmonary Disease, Bladder Disorders, Glioma, childhood ALL, Waldenstrom Macroglobulinemia, Oral Cancer, oesophageal cancer, Malignant Adenoma, Neuroendocrine Tumor, clear cell renal cell carcinoma, carcinoma of the bladder, Malignant neoplasm of parotid gland, Mesothelioma, Metastatic Cancer, Acute Myelogenous Leukemia (AML), adenocarcinomas, Gastric Cancer, Malignant neoplasm of vulva, cancer, renal, carcinoma of the cervix, rectal carcinoma, cancer, pancreatic, Prostate Cancer, Waldenstrom's Macroglobulinemia, cancer advanced, Melanoma, cancer of the pancreas, Soft Tissue Sarcoma, Oat cell carcinoma, Liver Cancer, soft tissue sarcomas, Lymphoproliferative Disorder, colorectal neoplasm, liver cancers, Malignant Mesothelioma, Thyroid Cancer, carcinoma of cervix, Small Bowel Cancer, Neoplasm Metastasis, Paraganglioma, cancer, hepatic, cancer, colorectal, Kaposi's Sarcoma, Malignant Pheochromocytoma/Paraganglioma, bladder disorder, cancer, liver, non-hodgkin's lymphoma (nhl), Bronchial Neoplasm, prostate cancers, chronic myelogenous leukemia, vaginal carcinoma, Central Nervous System Neoplasms, Parathyroid Disease, Bile duct carcinoma, Recurrent Ovarian Cancer, Solid Tumors, Brain Cancer, cancer of the esophagus, Adenoid Cystic Carcinoma, Metastatic Melanoma, Brain Tumor (Pediatric), small cell carcinoma of the lung, Ovarian Function, Adrenal Cancer, Testicular Cancer, Malignant neoplasm of ureter, Sarcoma, Stomach Discomfort, Thyroid Disorders, cns tumors, Bladder Cancer, colorectal cancers, acute myelogenous leukemia, synovial sarcoma, cervix cancer, skin cancer, CNS Malignancy, Bone Neoplasm, Parathyroid Adenoma, bone sarcoma, cancer ovarian, head and neck tumor, Colon Cancer Screening, Vaginal Cancer, Small Cell Lung Cancer, Gestational trophoblastic disease, anal carcinoma, skin cancers, carcinoid, Ovarian disorder, Malignant neoplasm of adrenal gland, Gastropathy, adrenal pheochromocytoma, Kidney Cancer, Lung Neoplasm, cervical cancer, uterine, Advanced Cancer, Nephropathy, Lymphocytic Leukemia, Acute, cancer of the bile duct, Renal Cell Carcinoma, Oral Cavity Cancer, All Solid Tumors, Head and Neck Cancer, central nervous system tumor, Cervical Cancer, ovarian tumors, head and neck neoplasms, Malignant neoplasm of kidney, Gastric Carcinoma, Liver Disease, Islet Ce417ll Cancer, Sarcoma (Pediatric), Malignant neoplasm of colon, breast carcinoma, leukemia, acute lymphoblastic, Lung Cancer, cancer of the cervix, Malignant neoplasm of brain, Fallopian Tube Cancer, Bone Cancer, Hereditary Neoplastic Syndrome, glioblastoma, cancer, thymic, Acute Myeloid Leukemia, oesophageal carcinoma, LIVER DISEASE, Biliary Tract Cancer, Neoplasm of unspecified nature of digestive system, Pharyngeal Neoplasm, Adenocarcinoma, cns neoplasm, pancreatic cancers, vulva cancer, Bladder Carcinoma, Stomach Cancer, Esophageal Cancer, Rectal disorder, parathyroid neoplasm, Esophageal Disorders, Urothelial Cancer, Disorder of uterus NOS, brainstem tumor, chondrosarcomas, colon carcinoma, small intestinal cancer, cancer of the ovary, multiple myeloma (mm), brain tumors, nasopharyngeal carcinoma, Chronic Myeloid Leukemia, Uterine Cancer, Urothelial Tract Cancer, Chondrosarcoma, Connective and Soft Tissue Neoplasm, sarcomas, Anal Cancer, Kidney Disease, Osteosarcoma, Skin Cancer, Carcinoma, ovarian carcinomas, Pancreatic disorder, Pancreatic Cancer, fallopian tube cancers, testis cancer, Lymphoma, Thyroid Adenoma, sclc, gastric cancers, Breast Cancer, Prostate Cancer, Early, Recurrent, Bone Metastases, Neoplasms, Unknown Primary, central nervous system cancer, Liver Disorders, Nasopharyngeal Cancer, tumors, colorectal, Advanced Malignancies, Metastasis, phaeochromocytoma, Cholangiocarcinoma, esophagus cancer, Pancreatic Disorders, bladder tumor, Malignant neoplasm of testis, Disorders of cervix NOS, Renal Cell Cancer, brain stem tumor, cervical carcinoma, Chronic myeloid leukemia, Thyroid disorder, neuroendocrine tumour, Renal Cancer, small cell carcinoma, acute lymphoid leukaemia, tumor, unknown primary, Hereditary Cancer Syndromes, tongue cancer, bladder cancer, malignant central nervous system tumor, melanoma, Malignant neoplasm of appendix, prostate carcinoma, acute lymphoblastic leukemia (all), Kidney Disease (Pediatric), Malignant neoplasm of tongue, thyroid carcinoma, Lung Disease, Non-Hodgkin's Lymphoma, Glioblastoma multiforme, central nervous system tumors, Glioblastoma Multiforme, cancer, hepatocellular, Lymphoproliferative disorders, Liver Metastases, Gestational Trophoblastic Neoplasia, Oral Neoplasm, Laryngeal Cancer, carcinoma of the cervix uteri, Malignant Melanoma, Multiple Myeloma, acute lymphoblastic leukemia, Astrocytoma, Esophageal Diseases, Parathyroid Cancer, Prostate Disorders, Vulvar Dysplasia and Carcinoma, Ovarian Cancer, Prostatic disorder, salivary gland cancer, Malignant neoplasm of penis, small cell carcinomas, Gliomas, cancer, breast, HEPATIC NEOPLASM, Uterine Serous Carcinoma, urinary tract neoplasm, Multiple Endocrine Neoplasia, Digestive System Neoplasms, Vulvar Carcinoma, meas, vulvar cancer, cancer, ovarian, cns tumor, head and neck cancer, Neurectoderma, brain stem tumors, thymus cancer, acute lymphocytic leukemia, Parathyroid Disorders, Esophageal Carcinoma, Malignant neoplasm of prostate, carcinoma lung, colorectal tumor, lung carcinoma, Pheochromocytoma, Urologic Cancer, Uterine Disorders
Treatment Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
Clinical Study IdentifierNCT04028479
SponsorTaproot Health
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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
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