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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695976
• Other study ID #: Pro00110247
• Status: Recruiting
• Start date: April 18, 2023
• Est. completion date: January 2029

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Mustafa Khasraw, MBChB, MD, FRCP, FRACP
• Phone: 919-684-5301
• Email: dukebrain1[@]dm.duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Glioma, Malignant

Locations

Country	Name	City	State
United States	The Preston Robert Tisch Brain Tumor Center at Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Personalis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Characterize the fragmentomic landscape of GBM	Median number of ctDNA fragments obtained from tumor tissue, pre-radiation serum specimen, and post-radiation serum specimen, and healthy controls.	6 months
Other	Spearman correlation between clinical descriptors and measures of ctDNA	Assess the association between degree and frequency of ctDNA shedding and clinical characteristics, such as molecular findings, histopathological characteristics, corticosteroid use, and bevacizumab use.	6 months
Other	Median and range for measures of tumor immune infiltration	Quantify the level of immune infiltration in the tumor, and assess its association with progression-free survival (PFS), overall survival (OS), and ctDNA detection.	6 months
Other	Hazard ratio for the relationship between chromosomal instability and OS or PFS	Assess the prognostic value of chromosomal instability/CAN burden, and assess its association with ctDNA from plasma.	6 months
Other	Spearman correlation between ctDNA and peripheral T cell function, autoantibodies.	Determine if peripheral T cell function and stemness or autoantibodies are association with ctDNA levels, or TME composition.	6 months
Primary	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
Primary	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

External Links

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