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Trial Title:
Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue
NCT ID:
NCT05756985
Condition:
Glioblastoma
Glioblastoma Multiforme
Gliosarcoma
Conditions: Official terms:
Glioblastoma
Gliosarcoma
Conditions: Keywords:
specimen banking
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Specimen Collection
Description:
Collect and preserve glioblastoma tissue for exploratory analyses to generate hypotheses
for future studies.
Arm group label:
Glioblastoma
Summary:
To collect and preserve glioblastoma tissue during standard of care tumor resection
surgery and blood for future molecular and genetic testing. Tissue for research will be
collected from three different regions within the same tumor to study how these regions
differ in their structure, DNA, and RNA and also to compare the data obtained from this
testing to imaging data found in the medical record. The goal of this study is to help us
better understand what the glioblastoma tumor tissue looks like and how it functions.
This understanding can lead to new therapies for the treatment of glioblastoma in the
future.
Criteria for eligibility:
Study pop:
Adults with GBM or gliosarcoma undergoing standard of care tumor resection surgery.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Have the appearance of high-grade glioma on magnetic resonance (MR) imaging if
allowed to consent and will undergo the procedure if the frozen is consistent with
glioblastoma or gliosarcoma OR Patients with a history of histologically confirmed
diagnosis of World Health Organization Grade glioblastoma or gliosarcoma that are
undergoing repeat resection of a recurrent tumor as identified on preoperative MR
imaging
2. Aged ≥ 18 years old
3. Contrast-enhancing tumor volume of at least 10 cc on the preoperative, volumetric
MRI within 1 month prior to surgery
4. Provision of signed and dated informed consent form by participant or legally
authorized representative (LAR), if applicable
Exclusion Criteria:
1. Has a history or current evidence of any medical condition, therapy, or laboratory
abnormality that might confound the results of the study or is not in the best
interest of the participant, in the opinion of the treating investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Miami Cancer Institute at Baptist Health, Inc.
Address:
City:
Miami
Zip:
33176
Country:
United States
Contact:
Last name:
Manmeet S Ahluwalia, M.D.
Phone:
786-596-2000
Email:
manmeeta@baptisthealth.net
Contact backup:
Last name:
Michael McDermott, M.D.
Phone:
(786) 596-2000
Email:
MWMCD@baptisthealth.net
Start date:
September 2024
Completion date:
September 2028
Lead sponsor:
Agency:
Baptist Health South Florida
Agency class:
Other
Collaborator:
Agency:
Miami Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Nico Corporation
Agency class:
Industry
Source:
Baptist Health South Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756985
http://cancer.baptisthealth.net
