MedDataX Logo

The Registry of Oncology Outcomes Associated with Testing and Treatment

NCT ID: NCT04028479

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-05

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Biomarker Testing (L)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DRUG

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.

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.

Biomarker Testing (L)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DRUG

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)

Intervention Type OTHER

Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biomarker Testing Molecular Testing Next-generation sequencing (NGS) Multiplex molecular testing Biologic therapy Targeted therapy Immunotherapy Chemotherapy Patient experience Quality of life Self-reporting

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taproot Health

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Razelle Kurzrock, MD

Role: STUDY_CHAIR

Moores Cancer Center at University of California at San Diego

Vivek Subbiah, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Jennifer Johnson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Raymond Bergan, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Teton Cancer Institute

Idaho Falls, Idaho, United States

Site Status

Oncology and Hematology of South Texas

Laredo, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28679092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23757002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30227640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27341594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27959688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25043853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28572459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26565654 (View on PubMed)

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 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.

Reference Type BACKGROUND
PMID: 29149611 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ROOT

Identifier Type: -

Identifier Source: org_study_id