NCT05480644

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Dec 2022Dec 2032

First Submitted

Initial submission to the registry

July 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

10 years

First QC Date

July 27, 2022

Last Update Submit

November 18, 2025

Conditions

Brain Tumor, PrimaryBrain Metastases, Adult

Outcome Measures

Primary Outcomes (1)

  • Number of circulating immune cells in peripheral blood

    reported as mean +/- standard deviation

    6 weeks post radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma for circulating tumor DNA analysis Whole blood for peripheral blood mononuclear cell and circulating immune cells

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Eugene Vaios, MD MBA

    Duke University Health System (DUHS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlin Bailey, RN OCN

CONTACT

(919) 668-3726Kaitlin.Bailey@duke.edu

Linda Kaltenbach, PhD

CONTACT

Linda.Kaltenbach@duke.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2022

First Posted

July 29, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)