GlioblastomaNCT05756985
Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue
An observational study of Glioblastoma and Glioblastoma Multiforme, run by Baptist Health South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme, Gliosarcoma
- What is being tested?
- Specimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2024to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with GBM or gliosarcoma undergoing standard of care tumor resection surgery.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Manmeet S Ahluwalia, M.D., 786-596-2000, manmeeta@baptisthealth.net
Michael McDermott, M.D., (786) 596-2000, MWMCD@baptisthealth.net
About this study
Official title: 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.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Gliosarcoma
- Being tested
- Specimen Collection
- Keywords
- specimen banking
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen CollectionProcedure or surgery
Collect and preserve glioblastoma tissue for exploratory analyses to generate hypotheses for future studies.
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma | Surgical tumor resection as standard of care and specimen collection Receives: Procedure: Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of glioblastoma (GBM) samples for analysis
Total number of GBM samples collected and preserved for analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start11 Dec 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Miami Cancer Institute, Nico Corporation
- Responsible party
- Sponsor
- Investigators
- Manmeet S Ahluwalia, M.D., Principal investigator, Miami Cancer Institute at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756985
- Sponsor's protocol ID
- 2022-SPEC-AHL-001
- Status last verified
- Jan 2026
- First submitted
- 24 Feb 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29432615Kumar 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.
PubMed 25608559Lee 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.
PubMed 28263318Prasanna 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.
PubMed 27778090
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue (PRESERVE GBM)
- ClinicalTrials.gov ID
- NCT05756985
- Acronym / sponsor ID
- 2022-SPEC-AHL-001
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Gliosarcoma
- Keywords
- specimen banking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Miami Cancer Institute, Nico Corporation
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma | – | Procedure: Specimen CollectionSurgical tumor resection as standard of care and specimen collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with GBM or gliosarcoma undergoing standard of care tumor resection surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen CollectionCollect and preserve glioblastoma tissue for exploratory analyses to generate hypotheses for future studies. | Procedure or surgery | Glioblastoma |
Primary outcome
Number of glioblastoma (GBM) samples for analysis
Time frame: 2 years
Total number of GBM samples collected and preserved for analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 29432615GLASS 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.
- Background: PubMed 25608559Kumar 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.
- Background: PubMed 28263318Lee 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.
- Background: PubMed 27778090Prasanna 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.
- Miami Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manmeet S Ahluwalia, M.D. principal investigator
Miami Cancer Institute at Baptist Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Glioblastoma Multiforme, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manmeet S Ahluwalia, M.D. ((786) 596-2000, manmeeta@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of glioblastoma (GBM) samples for analysis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756985, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.