GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM

A Study for Patients Newly Diagnosed With Glioblastoma Being Treated With Standard Radiotherapy and Temozolomide (TMZ) to Evaluate Tumor Response Via Liquid Biopsies (GRETeL)

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05695976

Enrollment

100

Registered

2023-01-25

Start date

2023-04-18

Completion date

2029-01-01

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma, Glioma, Malignant

Keywords

Khasraw, Glioblastoma, Glioma, Pro00110247, GRETEL, Duke

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Median cf/ctDNA concentration at pre- and post-radiation, as well as median change in ct/ctDNA concentration	6 months	Identify and describe changes in the cell free DNA (cfDNA) sequencing profiles of patients diagnosed with GBM in pre- versus post-radiation therapy samples, and to assess the association between these changes and clinical outcome, including progression free and overall survival
Median levels of cfDNA collected longitudinally after completion of radiation	6 months	Identify and describe changes over time after radiotherapy in the cfDNA sequencing profiles of patients diagnosed with GBM, and to assess the association between these longitudinal changes in cfDNA and clinical outcome, including progression free and overall survival

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMustafa Khasraw, MBChB, MD, FRCP, FRACP

Duke University

Outcome results