We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date July 27, 2022
First Posted Date July 29, 2022
Last Update Posted Date December 1, 2022
Estimated Study Start Date December 2022
Estimated Primary Completion Date December 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2022)
Number of circulating immune cells in peripheral blood [ Time Frame: 6 weeks post radiation therapy ]
reported as mean +/- standard deviation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
Official Title Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
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.
Detailed Description Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood plasma for circulating tumor DNA analysis Whole blood for peripheral blood mononuclear cell and circulating immune cells
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
Condition
  • Brain Tumor, Primary
  • Brain Metastases, Adult
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 27, 2022)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2032
Estimated Primary Completion Date December 2032   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kaitlin Bailey, RN (919) 668-3726 Kaitlin.Bailey@duke.edu
Contact: Joan Cahill, RN BNS OCN (919) 668-5211 Joan.Cahill@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05480644
Other Study ID Numbers Pro00110602
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor Duke University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Duke University
Verification Date November 2022