Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

NCT05756985 | Recruiting

• 1 other identifier: 2022-SPEC-AHL-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Glioblastoma Multiforme; Gliosarcoma

Keywords

specimen banking

Outcome Measures

Primary Outcomes (1)

• Number of glioblastoma (GBM) samples for analysis

  Total number of GBM samples collected and preserved for analysis

  2 years

Study Arms (1)

Glioblastoma

Surgical tumor resection as standard of care and specimen collection

Procedure: Specimen Collection

Interventions

Specimen Collection PROCEDURE

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

Glioblastoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with GBM or gliosarcoma undergoing standard of care tumor resection surgery.

You may qualify if:

• 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
• Aged ≥ 18 years old
• Contrast-enhancing tumor volume of at least 10 cc on the preoperative, volumetric MRI within 1 month prior to surgery
• Provision of signed and dated informed consent form by participant or legally authorized representative (LAR), if applicable

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Miami Cancer Institute: collaborator
• Nico Corporation: collaborator

Study Sites (1)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Related 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.

  PMID: 29432615 BACKGROUND

• 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.

  PMID: 25608559 BACKGROUND

• 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.

  PMID: 28263318 BACKGROUND

• 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.

  PMID: 27778090 BACKGROUND

Related Links

• Miami Cancer Institute

Biospecimen

Retention: SAMPLES WITH DNA

Blood: 50 mL (less than 4 tablespoons) Glioblastoma tissue: three geographically distinct samples from the same tumor, about 10 cubic centimeters in volume

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Manmeet S Ahluwalia, M.D.

  Miami Cancer Institute at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manmeet S Ahluwalia, M.D.

CONTACT

(786) 596-2000; manmeeta@baptisthealth.net

Michael McDermott, M.D.

CONTACT

(786) 596-2000; MWMCD@baptisthealth.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: December 11, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

US (1)