Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

Sponsor
Baptist Health South Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05756985
Collaborator
Miami Cancer Institute (Other), Nico Corporation (Industry)
120
1
48
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Specimen Collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue (PRESERVE GBM)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Glioblastoma

Surgical tumor resection as standard of care and specimen collection

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

Outcome Measures

Primary Outcome Measures

  1. Number of glioblastoma (GBM) samples for analysis [2 years]

    Total number of GBM samples collected and preserved for analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Miami Cancer Institute at Baptist Health, Inc. Miami Florida United States 33176

Sponsors and Collaborators

  • Baptist Health South Florida
  • Miami Cancer Institute
  • Nico Corporation

Investigators

  • Principal Investigator: Manmeet S Ahluwalia, M.D., Miami Cancer Institute at Baptist Health, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Baptist Health South Florida
ClinicalTrials.gov Identifier:
NCT05756985
Other Study ID Numbers:
  • 2022-SPEC-AHL-001
First Posted:
Mar 7, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Baptist Health South Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2023