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:
Duke University
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 |
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 |
|
||||||||
| 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 |
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:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| 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 |
|
||||||||
| IPD Sharing Statement |
|
||||||||
| 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 | ||||||||