Brain Tumor, PrimaryNCT05480644
Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
An observational study of Brain Tumor, Primary and Brain Metastases, Adult, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Primary, Brain Metastases, Adult
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with primary or metastatic brain tumors and treated in the Department of Radiation Oncology at Duke
Who may be able to join
- Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Linda Kaltenbach, PhD contact
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Kaitlin Bailey, RN, (919) 668-3726, Kaitlin.Bailey@duke.edu
Linda Kaltenbach, PhD, Linda.Kaltenbach@duke.edu
About this study
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.
Read the detailed description
Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.
- Conditions
- Brain Tumor, Primary, Brain Metastases, Adult
- Keywords
- biorepository
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating immune cells in peripheral blood
reported as mean +/- standard deviation
Measured: 6 weeks post radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Dec 2022
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene Vaios, MD MBA, Principal investigator, Duke University Health System (DUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480644
- Sponsor's protocol ID
- Pro00110602
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT05480644
- Acronym / sponsor ID
- Pro00110602
- Conditions
- Brain Tumor, Primary, Brain Metastases, Adult
- Keywords
- biorepository
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with primary or metastatic brain tumors and treated in the Department of Radiation Oncology at Duke
Key inclusion criteria (1 listed)
- Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of circulating immune cells in peripheral blood
Time frame: 6 weeks post radiation therapy
reported as mean +/- standard deviation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Kaltenbach, PhD contact
Eugene Vaios, MD MBA principal investigator
Duke University Health System (DUHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, Primary and Brain Metastases, Adult, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaitlin Bailey, RN OCN ((919) 668-3726, Kaitlin.Bailey@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating immune cells in peripheral blood (time frame: 6 weeks post radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.