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

NCT05695976 | Suspended DMC

• 1 other identifier: Pro00110247
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Glioma, Malignant

Keywords

Khasraw; Glioblastoma; Glioma; Pro00110247; GRETEL; Duke

Outcome Measures

Primary Outcomes (2)

• Median cf/ctDNA concentration at pre- and post-radiation, as well as median change in ct/ctDNA concentration

  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

  6 months

• Median levels of cfDNA collected longitudinally after completion of radiation

  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

  6 months

Other Outcomes (5)

• Characterize the fragmentomic landscape of GBM

  6 months

• Spearman correlation between clinical descriptors and measures of ctDNA

  6 months

• Median and range for measures of tumor immune infiltration

  6 months

Study Arms (2)

Pilot

The first 20 patients accrued to this study will be assayed to validate the performance of the assays developed by Personalis. This pilot sub-study will be analyzed in a "blinded" manner without clinical information.

Full Study

The remaining 80 patients accrued to this study (after the initial 20 patients accrue to the "Pilot" cohort).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients newly diagnosed with glioblastoma post-resection who are scheduled to receive standard radiation and chemotherapy (temozolomide).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Personalis Inc.: collaborator

Study Sites (1)

The Preston Robert Tisch Brain Tumor Center at Duke University

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Center at Duke University
• Duke Health

Biospecimen

Retention: SAMPLES WITH DNA

Tumor (archival) specimens will be obtained from the surgical resection and diagnosis of GBM and before initiation of radiotherapy. It is anticipated that a certain proportion of patients will need to undergo further tumor debulking after radiotherapy. In such instances, these post-radiotherapy re-resected tumor specimens will also be collected for later sequencing.

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Mustafa Khasraw, MBChB, MD, FRCP, FRACP

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 25, 2023
• Study Start: April 18, 2023
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)