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出境医 / 临床实验 / The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
Study Description
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.
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 100000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT) |
| Estimated Study Start Date : | April 5, 2021 |
| Estimated Primary Completion Date : | October 1, 2029 |
| Estimated Study Completion Date : | October 1, 2031 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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:
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:
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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.
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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:
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:
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:
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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.
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Outcome Measures
Primary Outcome Measures :
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 :
- 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
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| 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 |
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 17, 2019 | ||||||||||||
| First Posted Date | July 22, 2019 | ||||||||||||
| Last Update Posted Date | March 30, 2021 | ||||||||||||
| Estimated Study Start Date | April 5, 2021 | ||||||||||||
| Estimated Primary Completion Date | October 1, 2029 (Final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||||||
| Change History | |||||||||||||
| Current Secondary Outcome Measures |
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
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| Original Secondary Outcome Measures | Same as current | ||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title | The Registry of Oncology Outcomes Associated With Testing and Treatment | ||||||||||||
| Official Title | The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT) | ||||||||||||
| 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. | ||||||||||||
| 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] | ||||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 5 Years | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description:
Protocol does not require submission of samples, but catalogs location of specimens that can be requisitioned later
|
||||||||||||
| 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. | ||||||||||||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status | Not yet recruiting | ||||||||||||
| Estimated Enrollment |
100000 | ||||||||||||
| Original Estimated Enrollment | Same as current | ||||||||||||
| Estimated Study Completion Date | October 1, 2031 | ||||||||||||
| Estimated Primary Completion Date | October 1, 2029 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number | NCT04028479 | ||||||||||||
| Other Study ID Numbers | ROOT | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Taproot Health | ||||||||||||
| Study Sponsor | Taproot Health | ||||||||||||
| Collaborators | Not Provided | ||||||||||||
| Investigators |
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| PRS Account | Taproot Health | ||||||||||||
| Verification Date | March 2021 | ||||||||||||
