AdenocarcinomaROOTNCT04028479
The Registry of Oncology Outcomes Associated With Testing and Treatment
An observational study of Adenocarcinoma and Adenocystic Carcinoma, run by Taproot Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer
- What is being tested?
- Biomarker Testing (L), Systemic Treatment (T) and Patient Reported Outcomes (P)
- How many people
- 167 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2021to 31 Oct 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- patient is not a candidate or does not desire any treatment for their disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Teton Cancer Institute
Idaho Falls, Idaho, 83404
Oncology and Hematology of South Texas
Laredo, Texas, 78041
About this study
Official title: The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
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.
Read the 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.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer, Brain Tumor, Glioblastoma
- Being tested
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- 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
- Medical subject headings
- Adenocarcinoma, Carcinoma, Adenoid Cystic, Anus Neoplasms, Appendiceal Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker Testing (L)Diagnostic test
Also called Biomarker Testing, Molecular Testing, Next-generation sequencing (NGS), Multiplex molecular testing
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.
Systemic Treatment (T)Drug
Also called Biologic therapy, Targeted therapy, Immunotherapy, Chemotherapy
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.
Patient Reported Outcomes (P)Other
Also called Patient experience, Quality of life, Self-reporting
Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Biomarker Testing (L); Drug: Systemic Treatment (T) | |
| 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. Receives: Diagnostic Test: Biomarker Testing (L); Drug: Systemic Treatment (T); Other: Patient Reported Outcomes (P) | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response (BOR) - 1st line of therapy
The best overall response for 1st line of therapy as determined by physician assessment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5th line of therapy, on average less than 1 year
Secondary outcomes (1)
Overall survival (OS)
The overall survival of a patient from the time of being diagnosed with advanced disease until death
Measured: through study completion, on average less than 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start5 May 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Taproot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Razelle Kurzrock, MD, Study chair, Moores Cancer Center at University of California at San DiegoVivek Subbiah, MD, Principal investigator, M.D. Anderson Cancer CenterJennifer Johnson, MD, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRaymond Bergan, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028479
- Sponsor's protocol ID
- ROOT
- Acronym
- ROOT
- Status last verified
- Dec 2024
- First submitted
- 17 Jul 2019
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will likely be shared, but will be determined by participating clinical sites.
Publications
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.
PubMed 28679092Boland 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.
PubMed 23757002Morash 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.
PubMed 30227640Korphaisarn K, Kopetz S. BRAF-Directed Therapy in Metastatic Colorectal Cancer. Cancer J. 2016 May-Jun;22(3):175-8. doi: 10.1097/PPO.0000000000000189.
PubMed 27341594Sherman 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.
PubMed 27959688Kaplan 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.
PubMed 25043853AACR 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.
PubMed 28572459Dickson 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.
PubMed 26565654Conley 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.
PubMed 29149611