Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

March 7, 2024 updated by: Baptist Health South Florida

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of glioblastoma (GBM) samples for analysis
Time Frame: 2 years
Total number of GBM samples collected and preserved for analysis
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Collaborators

Nico Corporation
Miami Cancer Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-SPEC-AHL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma

Clinical Trials on Specimen Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe