An observational study in Adenocarcinoma, Adenocystic Carcinoma and Anal Cancer, sponsored by Taproot Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Taproot Health · Observational
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.
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.
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.
Exclusion Criteria:
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) · Drug: Systemic Treatment (T)
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) · Drug: Systemic Treatment (T) · Other: Patient Reported Outcomes (P)
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.
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.
Also known as: Biomarker Testing, Molecular Testing, Next-generation sequencing (NGS), Multiplex molecular 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.
Also known as: Biologic therapy, Targeted therapy, Immunotherapy, Chemotherapy
Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.
Also known as: Patient experience, Quality of life, Self-reporting
Best overall response (BOR) - 1st line of therapy
The best overall response for 1st line of therapy as determined by physician assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5th line of therapy, on average less than 1 year
Overall survival (OS)
The overall survival of a patient from the time of being diagnosed with advanced disease until death
Time frame: through study completion, on average less than 3 years
Plan to share: Undecided — IPD will likely be shared, but will be determined by participating clinical sites.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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