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

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ClinicalTrials.gov Identifier: NCT05695976
Recruitment Status : Recruiting
First Posted : January 25, 2023
Last Update Posted : April 17, 2024
Sponsor:
Collaborator:
Personalis Inc.
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date December 20, 2022
First Posted Date January 25, 2023
Last Update Posted Date April 17, 2024
Actual Study Start Date April 18, 2023
Estimated Primary Completion Date January 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2023)
  • Median cf/ctDNA concentration at pre- and post-radiation, as well as median change in ct/ctDNA concentration [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2023)
  • Characterize the fragmentomic landscape of GBM [ Time Frame: 6 months ]
    Median number of ctDNA fragments obtained from tumor tissue, pre-radiation serum specimen, and post-radiation serum specimen, and healthy controls.
  • Spearman correlation between clinical descriptors and measures of ctDNA [ Time Frame: 6 months ]
    Assess the association between degree and frequency of ctDNA shedding and clinical characteristics, such as molecular findings, histopathological characteristics, corticosteroid use, and bevacizumab use.
  • Median and range for measures of tumor immune infiltration [ Time Frame: 6 months ]
    Quantify the level of immune infiltration in the tumor, and assess its association with progression-free survival (PFS), overall survival (OS), and ctDNA detection.
  • Hazard ratio for the relationship between chromosomal instability and OS or PFS [ Time Frame: 6 months ]
    Assess the prognostic value of chromosomal instability/CAN burden, and assess its association with ctDNA from plasma.
  • Spearman correlation between ctDNA and peripheral T cell function, autoantibodies. [ Time Frame: 6 months ]
    Determine if peripheral T cell function and stemness or autoantibodies are association with ctDNA levels, or TME composition.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Probability Sample
Study Population Patients newly diagnosed with glioblastoma post-resection who are scheduled to receive standard radiation and chemotherapy (temozolomide).
Condition
  • Glioblastoma
  • Glioma, Malignant
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 20, 2023)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2029
Estimated Primary Completion Date January 2029   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mustafa Khasraw, MBChB, MD, FRCP, FRACP 919-684-5301 dukebrain1@dm.duke.edu
Contact: Stevie Threatt 919-684-5301 dukebrain1@dm.duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05695976
Other Study ID Numbers Pro00110247
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor Duke University
Original Study Sponsor Same as current
Collaborators Personalis Inc.
Investigators
Principal Investigator: Mustafa Khasraw, MBChB, MD, FRCP, FRACP Duke University
PRS Account Duke University
Verification Date April 2024