The Registry of Oncology Outcomes Associated with Testing and Treatment

NCT04028479 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 167

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

Interventions

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.

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

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.

Sponsors & Collaborators

  • Taproot Health

    lead INDUSTRY

Principal Investigators

  • Razelle Kurzrock, MD · Moores Cancer Center at University of California at San Diego

  • Vivek Subbiah, MD · M.D. Anderson Cancer Center

  • Jennifer Johnson, MD, PhD · Sidney Kimmel Cancer Center at Thomas Jefferson University

  • Raymond Bergan, MD · OHSU Knight Cancer Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028479 on ClinicalTrials.gov