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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04028479
Recruitment Status : Not yet recruiting
First Posted : July 22, 2019
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Taproot Health

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.

Condition or disease Intervention/treatment
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 Diagnostic Test: Biomarker Testing (L) Drug: Systemic Treatment (T) Other: Patient Reported Outcomes (P)

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 35000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Master Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 1, 2029
Estimated Study Completion Date : October 1, 2031


Group/Cohort Intervention/treatment
Validation Cohoirt
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.
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.
Other Names:
  • Biomarker Testing
  • Molecular Testing
  • Next-generation sequencing (NGS)
  • Multiplex molecular 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 Names:
  • Biologic therapy
  • Targeted therapy
  • Immunotherapy
  • Chemotherapy

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.
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.
Other Names:
  • Biomarker Testing
  • Molecular Testing
  • Next-generation sequencing (NGS)
  • Multiplex molecular 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 Names:
  • Biologic therapy
  • Targeted therapy
  • Immunotherapy
  • Chemotherapy

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.
Other Names:
  • Patient experience
  • Quality of life
  • Self-reporting




Primary Outcome Measures :
  1. Best overall response (BOR) - 1st line of therapy [ Time Frame: 1st line of therapy, on average less than 1 year ]
    The best overall response for 1st line of therapy as determined by physician assessment

  2. Best overall response (BOR) - 2nd line of therapy [ Time Frame: 2nd line of therapy, on average less than 1 year ]
    The best overall response for 2nd line of therapy as determined by physician assessment

  3. Best overall response (BOR) - 3rd line of therapy [ Time Frame: 3rd line of therapy, on average less than 1 year ]
    The best overall response for 3rd line of therapy as determined by physician assessment

  4. Best overall response (BOR) - 4th line of therapy [ Time Frame: 4th line of therapy, on average less than 1 year ]
    The best overall response for 4th line of therapy as determined by physician assessment

  5. Best overall response (BOR) - 5th line of therapy [ Time Frame: 5th line of therapy, on average less than 1 year ]
    The best overall response for 5th line of therapy as determined by physician assessment

  6. Progression-free survival (PFS) - 1st line of therapy [ Time Frame: 1st line of therapy, on average less than 1 year ]
    The progression free survival for 1st line of therapy as determined by physician assessment

  7. Progression-free survival (PFS) - 2nd line of therapy [ Time Frame: 2nd line of therapy, on average less than 1 year ]
    The progression free survival for 2nd line of therapy as determined by physician assessment

  8. Progression-free survival (PFS) - 3rd line of therapy [ Time Frame: 3rd line of therapy, on average less than 1 year ]
    The progression free survival for 3rd line of therapy as determined by physician assessment

  9. Progression-free survival (PFS) - 4th line of therapy [ Time Frame: 4th line of therapy, on average less than 1 year ]
    The progression free survival for 4th line of therapy as determined by physician assessment

  10. Progression-free survival (PFS) - 5th line of therapy [ Time Frame: 5th line of therapy, on average less than 1 year ]
    The progression free survival for 5th line of therapy as determined by physician assessment


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: through study completion, on average less than 3 years ]
    The overall survival of a patient from the time of being diagnosed with advanced disease until death


Biospecimen Retention:   Samples With DNA
Protocol does not require submission of samples, but catalogs location of specimens that can be requisitioned later


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028479


Contacts
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Contact: Judy Taylor (801) 396-5190 judy.taylor@taprootco.com
Contact: Jennifer Rock (801) 396-5190 jennifer.rock@taprootco.com

Sponsors and Collaborators
Taproot Health
Investigators
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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
Publications of Results:
Other Publications:

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Responsible Party: Taproot Health
ClinicalTrials.gov Identifier: NCT04028479    
Other Study ID Numbers: ROOT
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will likely be shared, but will be determined by participating clinical sites.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taproot Health:
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
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Colonic Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Fallopian Tube Neoplasms
Neuroendocrine Tumors
Cholangiocarcinoma
Salivary Gland Neoplasms
Carcinoid Tumor
Anus Neoplasms
Bile Duct Neoplasms
Head and Neck Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Stomach Neoplasms
Uterine Neoplasms
Testicular Neoplasms
Tongue Neoplasms
Trophoblastic Neoplasms
Penile Neoplasms
Ureteral Neoplasms
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Laryngeal Neoplasms
Bone Neoplasms
Adrenal Gland Neoplasms
Parathyroid Neoplasms
Neoplasms, Unknown Primary
Appendiceal Neoplasms
Thymus Neoplasms