Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

NCT ID: NCT05756985

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-11

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma Glioblastoma Multiforme Gliosarcoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Glioblastoma

Surgical tumor resection as standard of care and specimen collection

Specimen Collection

Intervention Type PROCEDURE

Collect and preserve glioblastoma tissue for exploratory analyses to generate hypotheses for future studies.

Interventions

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Specimen Collection

Collect and preserve glioblastoma tissue for exploratory analyses to generate hypotheses for future studies.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Miami Cancer Institute

OTHER

Sponsor Role collaborator

Nico Corporation

INDUSTRY

Sponsor Role collaborator

Baptist Health South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manmeet S Ahluwalia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Miami Cancer Institute at Baptist Health, Inc.

Locations

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Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manmeet S Ahluwalia, M.D.

Role: CONTACT

(786) 596-2000

Michael McDermott, M.D.

Role: CONTACT

(786) 596-2000

Facility Contacts

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Manmeet S Ahluwalia, M.D.

Role: primary

786-596-2000

Michael McDermott, M.D.

Role: backup

(786) 596-2000

References

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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.

Reference Type BACKGROUND
PMID: 29432615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25608559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28263318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27778090 (View on PubMed)

Related Links

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http://cancer.baptisthealth.net

Miami Cancer Institute

Other Identifiers

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2022-SPEC-AHL-001

Identifier Type: -

Identifier Source: org_study_id

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