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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

Study Description
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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.

Condition or disease
Glioblastoma Glioma, Malignant

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : April 18, 2023
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients newly diagnosed with glioblastoma post-resection who are scheduled to receive standard radiation and chemotherapy (temozolomide).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05695976


Contacts
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Contact: Mustafa Khasraw, MBChB, MD, FRCP, FRACP 919-684-5301 dukebrain1@dm.duke.edu
Contact: Stevie Threatt 919-684-5301 dukebrain1@dm.duke.edu

Locations
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United States, North Carolina
The Preston Robert Tisch Brain Tumor Center at Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Mustafa Khasraw, MBChB, MD, FRCP, FRACP    919-684-5301    dukebrain1@dm.duke.edu   
Contact: Stevie Threatt    919-684-5301    dukebrain1@dm.duke.edu   
Sponsors and Collaborators
Duke University
Personalis Inc.
Investigators
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Principal Investigator: Mustafa Khasraw, MBChB, MD, FRCP, FRACP Duke University
More Information
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Additional Information:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05695976    
Other Study ID Numbers: Pro00110247
First Posted: January 25, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Khasraw
Glioblastoma
Glioma
 Pro00110247
GRETEL
Duke
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue