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NCT05756985 Clinical Trial

Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

Glioblastoma Clinical Trial

Official title:
Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue (PRESERVE GBM)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05756985
Other study ID # 2022-SPEC-AHL-001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2028

Study information
Verified date March 2024
Source Baptist Health South Florida
Contact Manmeet S Ahluwalia, M.D.
Phone (786) 596-2000
Email manmeeta@baptisthealth.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date June 2028
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Specimen Collection
Collect and preserve glioblastoma tissue for exploratory analyses to generate hypotheses for future studies.

Locations
Country Name City State
United States Miami Cancer Institute at Baptist Health, Inc. Miami Florida

Sponsors (3)
Lead Sponsor Collaborator
Baptist Health South Florida Miami Cancer Institute, Nico Corporation

Country where clinical trial is conducted

United States, 

References & Publications (4)

GLASS Consortium. Glioma through the looking GLASS: molecular evolution of diffuse gliomas and the Glioma Longitudinal Analysis Consortium. Neuro Oncol. 2018 Jun 18;20(7):873-884. doi: 10.1093/neuonc/noy020. — View Citation

Kumar A, Boyle EA, Tokita M, Mikheev AM, Sanger MC, Girard E, Silber JR, Gonzalez-Cuyar LF, Hiatt JB, Adey A, Lee C, Kitzman JO, Born DE, Silbergeld DL, Olson JM, Rostomily RC, Shendure J. Deep sequencing of multiple regions of glial tumors reveals spatial heterogeneity for mutations in clinically relevant genes. Genome Biol. 2014 Dec 3;15(12):530. doi: 10.1186/s13059-014-0530-z. — View Citation

Lee JK, Wang J, Sa JK, Ladewig E, Lee HO, Lee IH, Kang HJ, Rosenbloom DS, Camara PG, Liu Z, van Nieuwenhuizen P, Jung SW, Choi SW, Kim J, Chen A, Kim KT, Shin S, Seo YJ, Oh JM, Shin YJ, Park CK, Kong DS, Seol HJ, Blumberg A, Lee JI, Iavarone A, Park WY, Rabadan R, Nam DH. Spatiotemporal genomic architecture informs precision oncology in glioblastoma. Nat Genet. 2017 Apr;49(4):594-599. doi: 10.1038/ng.3806. Epub 2017 Mar 6. — View Citation

Prasanna P, Patel J, Partovi S, Madabhushi A, Tiwari P. Radiomic features from the peritumoral brain parenchyma on treatment-naive multi-parametric MR imaging predict long versus short-term survival in glioblastoma multiforme: Preliminary findings. Eur Radiol. 2017 Oct;27(10):4188-4197. doi: 10.1007/s00330-016-4637-3. Epub 2016 Oct 24. Erratum In: Eur Radiol. 2017 Jun 12;: — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of glioblastoma (GBM) samples for analysis Total number of GBM samples collected and preserved for analysis 2 years
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