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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

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