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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05480644
Recruitment Status : Recruiting
First Posted : July 29, 2022
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease
Brain Tumor, Primary Brain Metastases, Adult

Detailed Description:
Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : December 2032
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of circulating immune cells in peripheral blood [ Time Frame: 6 weeks post radiation therapy ]
    reported as mean +/- standard deviation


Biospecimen Retention:   Samples With DNA
Blood plasma for circulating tumor DNA analysis Whole blood for peripheral blood mononuclear cell and circulating immune cells

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Participation in other blood repository research protocols at Duke
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05480644


Contacts
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Contact: Kaitlin Bailey, RN (919) 668-3726 Kaitlin.Bailey@duke.edu
Contact: Joan Cahill, RN BNS OCN (919) 668-5211 Joan.Cahill@duke.edu

Locations
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United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kaitlin Bailey, RN    919-668-3726    Kaitlin.Bailey@duke.edu   
Contact: Joan Cahill, BSN OCN CCRP    (919) 668-5211    Joan.Cahill@duke.edu   
Principal Investigator: Scott Floyd, MD PhD         
Principal Investigator: Zach Reitman, MD PhD         
Sponsors and Collaborators
Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05480644    
Other Study ID Numbers: Pro00110602
First Posted: July 29, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases