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Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287063
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be non-invasively identified using imaging phenotypes that identify regionally distinct areas of tumor with genetic alterations that drive tumor resistance pathways. The researchers propose a unique approach to assess initial GBM heterogeneity by performing histological and genomic analysis of biopsies targeted by advanced MRI before treatment.

Condition or disease Intervention/treatment
Glioblastoma Other: Tumor Biopsy

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy


Intervention Details:
  • Other: Tumor Biopsy
    Stereotactic biopsies will be performed prior to resection.


Primary Outcome Measures :
  1. Identify candidate genes with differential expression in therapy-resistant imaging subvolumes [ Time Frame: At time of surgery ]

Biospecimen Retention:   Samples With DNA
Specimens will be analyzed with next generation sequencing (NGS). The primary objective is to identify candidate genes with differential expression in therapy-resistant imaging subvolumes.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with glioblastoma eligible for surgical biopsy and/or resection
Criteria

Inclusion Criteria:

  • Suspected newly diagnosed or recurrent supratentorial glioblastoma eligible for surgical biopsy and/or resection
  • Patients must be 18 years of age or older
  • Study-specific informed consent approved for this purpose by the IRB of the University of Michigan

Exclusion Criteria:

  • Patients unable to undergo MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287063


Contacts
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Contact: Michelle Kim, M.D. 734-936-7810 michekim@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Michelle Kim, M.D.    734-936-7810    michekim@umich.edu   
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Michelle Kim, M.D. University of Michigan
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03287063    
Other Study ID Numbers: UMCC 2017.094
HUM00134165 ( Other Identifier: University of Michigan )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue