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Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue

Study Purpose

Recent experiments are giving researchers insight into the changes (mutations) that occur in an individual brain tumor cell compared to a normal cell. Currently, we do not have enough knowledge about how uniform these changes are throughout a single brain tumor and if different regions of a brain tumor have different groupings of changes. By obtaining multiple samples of the tumor from various regions during surgery, it will allow researchers to better understand these changes, with the hope that they will lead to new discoveries in the diagnosis and treatment of brain tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants who have the appearance of high grade glioma on MR imaging are allowed to consent and will undergo the procedure if the frozen is consistent with World Health Organization Grade IV glioma (glioblastoma or gliosarcoma) OR.
  • - Participants with a history of histologically-confirmed diagnosis of World Health Organization Grade IV glioma (glioblastoma or gliosarcoma) that are undergoing repeat resection of a recurrent tumor as identified on preoperative MR imaging.
  • - Contrast-enhancing tumor volume of at least 15 cc on the preoperative, volumetric MRI within 1 month prior to surgery.
  • - Karnofsky performance status of 70 or higher.
  • - The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • - Screening/Baseline laboratory values must meet the following criteria within 1 month prior to surgery: - Hematological.
  • - Absolute neutrophil count (ANC): ≥ 1500/µL.
  • - Platelets ≥100 000/µL.
  • - Hemoglobin ≥ 9.0 g/dL or ≥5.6 mmol/L ----Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
  • - Renal.
---Creatinine OR Measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl) ≤ 1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN.
  • - Creatinine clearance (CrCl) should be calculated per institutional standard.
  • - Coagulation.
---International normalized ratio (INR) OR prothrombin time (PT). Activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
  • - Miscellaneous.
  • - Urine or Serum Pregnancy Test ----Negative (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal).

Exclusion Criteria:

  • - Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • - Is pregnant.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04545177
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Case Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alireza Mohammadi, MD
Principal Investigator Affiliation Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

This is a single site, interventional cohort study to assess the feasibility of the NICO Myriad and Tissue Preservation System (TPS) to collect and preserve biologically active tissue in 5 prospectively-enrolled participants with Glioblastoma (GBM) undergoing surgical resection. The primary objective of this study is to assess the viability of tumor tissue obtained by the NICO Myriad and Tissue Preservation System (TPS) via an automated, standardized methodology in participants undergoing surgery.The exploratory objective of this study is to assess the spatial genomic and transcriptomic heterogeneity of GBM tumors in 3 locations via preoperative annotation and stereotactic guidance

Arms & Interventions

Arms

Experimental: Tissue Preservation System (TPS)

Tumor tissue will be obtained, processed, and then transported remotely to undergo multiple tests, including gene panel DNA sequencing, DNA methylation array, and bulk as well as single-cell transcriptome analyses (RNA-seq)

Interventions

Device: - NICO Myriad and Tissue Preservation System (TPS)

Tumor tissue will be obtained by the NICO Myriad and Tissue Preservation System (TPS) via an automated, standardized methodology

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

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