The Registry of Oncology Outcomes Associated with Testing and Treatment
ROOT
1 other identifier
observational
167
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 22, 2019
CompletedStudy Start
First participant enrolled
May 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedDecember 18, 2024
December 1, 2024
3.5 years
July 17, 2019
December 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
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
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
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
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
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
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
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
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
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 Outcomes (1)
Overall survival (OS)
through study completion, on average less than 3 years
Study Arms (3)
Validation Cohort
Patients enrolled into the study to allow validation of a specific element, process, or endpoint. Validation will be done showing concordance with traditional interventional trial standards.
Analysis Cohorts
Patient who are enrolled into the study to allow analysis to determine any association, effect, or benefit. Cohorts can be determined prospectively and/or retrospectively for data already collected, Cohorts are identified to highlight collection of information on patients who are already receiving any treatment or testing as determined by the physician and patient independent of this study. Because many analysis cohorts will be determined in patients already enrolled in the study, this group is inclusive of many different sub-groupings or specific analysis cohorts of patients.
Retrospective Chart Review Cohorts
This arm will use retrospective data obtained through systematic chart review on previously seen patients to compare, contrast, or enhance the efforts of the prospective arms. Because most RWD has been traditionally obtained through retrospective methods, this is also considered the "control arm." Data in this arm will be collected without any patient identifiers. This arm is optional.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- patient is not a candidate or does not desire any treatment for their disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taproot Healthlead
Study Sites (2)
Teton Cancer Institute
Idaho Falls, Idaho, 83404, United States
Oncology and Hematology of South Texas
Laredo, Texas, 78041, United States
Related Publications (9)
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.
PMID: 28679092BACKGROUNDBoland 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.
PMID: 23757002BACKGROUNDMorash 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.
PMID: 30227640BACKGROUNDKorphaisarn K, Kopetz S. BRAF-Directed Therapy in Metastatic Colorectal Cancer. Cancer J. 2016 May-Jun;22(3):175-8. doi: 10.1097/PPO.0000000000000189.
PMID: 27341594BACKGROUNDSherman 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.
PMID: 27959688BACKGROUNDKaplan 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.
PMID: 25043853BACKGROUNDAACR 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.
PMID: 28572459BACKGROUNDDickson 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.
PMID: 26565654BACKGROUNDConley 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 Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus. Cell. 2017 Nov 16;171(5):982-986. doi: 10.1016/j.cell.2017.10.032.
PMID: 29149611BACKGROUND
Biospecimen
Protocol does not require submission of samples, but catalogs location of specimens that can be requisitioned later
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 22, 2019
Study Start
May 5, 2021
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
December 18, 2024
Record last verified: 2024-12