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Trial Title:
GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM
NCT ID:
NCT05695976
Condition:
Glioblastoma
Glioma, Malignant
Conditions: Official terms:
Glioblastoma
Glioma
Conditions: Keywords:
Khasraw
Glioblastoma
Glioma
Pro00110247
GRETEL
Duke
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The purpose of this study is to better define longitudinal genomic alterations in
patients with glioblastoma (GBM), and to determine if plasma circulating tumor DNA
(ctDNA) or cell free DNA (cfDNA) is associated with disease recurrence, survival, tumor
characteristics, and/or peripheral immunosuppression.
Criteria for eligibility:
Study pop:
Patients newly diagnosed with glioblastoma post-resection who are scheduled to receive
standard radiation and chemotherapy (temozolomide).
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- Patients newly diagnosed with malignant glioma, IDH wildtype who have undergone
surgical resection for their tumor and who are planned for standard of care
radiation therapy with concurrent temozolomide (i.e., at least 59 Gy in 30 fractions
over 6 weeks)
- Patients must have leftover tissue available from the surgical resection of their
tumor available to request for this research.
- Able to undergo MRI of brain with and without contrast
- Signed informed consent approved by the Institutional Review Board (IRB)
Exclusion Criteria:
- Prior, unrelated malignancy requiring current active treatment with the exception of
cervical carcinoma in situ and adequately treated basal cell or squamous cell
carcinoma of the skin
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Preston Robert Tisch Brain Tumor Center at Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Phone:
919-684-5301
Email:
dukebrain1@dm.duke.edu
Contact backup:
Last name:
Stevie Threatt
Phone:
919-684-5301
Email:
dukebrain1@dm.duke.edu
Start date:
April 18, 2023
Completion date:
January 2029
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
Personalis Inc.
Agency class:
Industry
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05695976
http://tischbraintumorcenter.duke.edu/
http://www.dukehealth.org/clinical-trials