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

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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

Tracking Information
First Submitted Date September 15, 2017
First Posted Date September 19, 2017
Last Update Posted Date July 20, 2020
Actual Study Start Date July 5, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2017)
Identify candidate genes with differential expression in therapy-resistant imaging subvolumes [ Time Frame: At time of surgery ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
Official Title A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Patients with glioblastoma eligible for surgical biopsy and/or resection
Condition Glioblastoma
Intervention Other: Tumor Biopsy
Stereotactic biopsies will be performed prior to resection.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 15, 2017)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michelle Kim, M.D. 734-936-7810 michekim@umich.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03287063
Other Study ID Numbers UMCC 2017.094
HUM00134165 ( Other Identifier: University of Michigan )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor University of Michigan Rogel Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Michelle Kim, M.D. University of Michigan
PRS Account University of Michigan Rogel Cancer Center
Verification Date June 2020