Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors

November 18, 2025 updated by: Duke University
The purpose of this protocol is to create a repository of blood samples from patients diagnosed with primary and metastatic brain tumors who are being seen in the Department of Radiation Oncology at Duke Cancer Center.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zach Reitman, MD PhD
        • Principal Investigator:
          • Eugene Vaios, MD MBA
        • Principal Investigator:
          • Scott Flody, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with primary or metastatic brain tumors and treated in the Department of Radiation Oncology at Duke

Description

Inclusion Criteria:

  • Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of circulating immune cells in peripheral blood
Time Frame: 6 weeks post radiation therapy
reported as mean +/- standard deviation
6 weeks post radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Eugene Vaios, MD MBA, Duke University Health System (DUHS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

July 27, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Estimated)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00110602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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