The Registry of Oncology Outcomes Associated With Testing and Treatment

Breast Cancer Clinical Trial

— ROOT  

Official title:

The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028479
• Other study ID #: ROOT
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: October 1, 2031

Study information

• Verified date: November 2023
• Source: Taproot Health
• Contact: Lori Miles
• Phone: (801) 396-5190
• Email: lori.miles[@]taprootco.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: October 1, 2031
• Est. primary completion date: October 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Biomarker Testing (L)
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.

Drug:
• Systemic Treatment (T)
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.

Other:
• Patient Reported Outcomes (P)
Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.

Locations

Country	Name	City	State
United States	Teton Cancer Institute	Idaho Falls	Idaho
United States	Oncology and Hematology of South Texas	Laredo	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Taproot Health

Country where clinical trial is conducted

United States, 

References & Publications (9)

AACR Project GENIE Consortium. AACR Project GENIE: Powering Precision Medicine through an International Consortium. Cancer Discov. 2017 Aug;7(8):818-831. doi: 10.1158/2159-8290.CD-17-0151. Epub 2017 Jun 1. — View Citation

Boland JF, Chung CC, Roberson D, Mitchell J, Zhang X, Im KM, He J, Chanock SJ, Yeager M, Dean M. The new sequencer on the block: comparison of Life Technology's Proton sequencer to an Illumina HiSeq for whole-exome sequencing. Hum Genet. 2013 Oct;132(10):1153-63. doi: 10.1007/s00439-013-1321-4. Epub 2013 Jun 12. — View Citation

Conley RB, Dickson D, Zenklusen JC, Al Naber J, Messner DA, Atasoy A, Chaihorsky L, Collyar D, Compton C, Ferguson M, Khozin S, Klein RD, Kotte S, Kurzrock R, Lin CJ, Liu F, Marino I, McDonough R, McNeal A, Miller V, Schilsky RL, Wang LI. Core Clinical Da — View Citation

Dickson DJ, Pfeifer JD. Real-world data in the molecular era-finding the reality in the real world. Clin Pharmacol Ther. 2016 Feb;99(2):186-97. doi: 10.1002/cpt.300. Epub 2016 Jan 12. — View Citation

Kaplan RM, Chambers DA, Glasgow RE. Big data and large sample size: a cautionary note on the potential for bias. Clin Transl Sci. 2014 Aug;7(4):342-6. doi: 10.1111/cts.12178. Epub 2014 Jul 15. — View Citation

Korphaisarn K, Kopetz S. BRAF-Directed Therapy in Metastatic Colorectal Cancer. Cancer J. 2016 May-Jun;22(3):175-8. doi: 10.1097/PPO.0000000000000189. — View Citation

Morash M, Mitchell H, Beltran H, Elemento O, Pathak J. The Role of Next-Generation Sequencing in Precision Medicine: A Review of Outcomes in Oncology. J Pers Med. 2018 Sep 17;8(3):30. doi: 10.3390/jpm8030030. — View Citation

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216. No abstract available. — View Citation

Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall response (BOR) - 1st line of therapy	The best overall response for 1st line of therapy as determined by physician assessment	1st line of therapy, on average less than 1 year
Primary	Best overall response (BOR) - 2nd line of therapy	The best overall response for 2nd line of therapy as determined by physician assessment	2nd line of therapy, on average less than 1 year
Primary	Best overall response (BOR) - 3rd line of therapy	The best overall response for 3rd line of therapy as determined by physician assessment	3rd line of therapy, on average less than 1 year
Primary	Best overall response (BOR) - 4th line of therapy	The best overall response for 4th line of therapy as determined by physician assessment	4th line of therapy, on average less than 1 year
Primary	Best overall response (BOR) - 5th line of therapy	The best overall response for 5th line of therapy as determined by physician assessment	5th line of therapy, on average less than 1 year
Primary	Progression-free survival (PFS) - 1st line of therapy	The progression free survival for 1st line of therapy as determined by physician assessment	1st line of therapy, on average less than 1 year
Primary	Progression-free survival (PFS) - 2nd line of therapy	The progression free survival for 2nd line of therapy as determined by physician assessment	2nd line of therapy, on average less than 1 year
Primary	Progression-free survival (PFS) - 3rd line of therapy	The progression free survival for 3rd line of therapy as determined by physician assessment	3rd line of therapy, on average less than 1 year
Primary	Progression-free survival (PFS) - 4th line of therapy	The progression free survival for 4th line of therapy as determined by physician assessment	4th line of therapy, on average less than 1 year
Primary	Progression-free survival (PFS) - 5th line of therapy	The progression free survival for 5th line of therapy as determined by physician assessment	5th line of therapy, on average less than 1 year
Secondary	Overall survival (OS)	The overall survival of a patient from the time of being diagnosed with advanced disease until death	through study completion, on average less than 3 years