Clinical trial NCT05756985: Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue
Official title: Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue (PRESERVE GBM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma
Glioblastoma Multiforme
Gliosarcoma
Keywords: specimen banking
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Miami Cancer Institute
name: Nico Corporation
First posted: 2023-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with GBM or gliosarcoma undergoing standard of care tumor resection surgery.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of glioblastoma (GBM) samples for analysis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc.
state: Florida
Study officials:
affiliation: Miami Cancer Institute at Baptist Health, Inc.
name: Manmeet S Ahluwalia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.