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Trial record 30 of 1115 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

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ClinicalTrials.gov Identifier: NCT03194971
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Peter LaViolette, Medical College of Wisconsin

Tracking Information
First Submitted Date June 12, 2017
First Posted Date June 21, 2017
Last Update Posted Date November 19, 2019
Actual Study Start Date June 1, 2017
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2017)
Underlying pathological signatures of TTField therapy compared to patients naïve to TTField therapy using pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells . [ Time Frame: Through completion of study, an average of four years. ]
Tissue samples will be obtained at autopsy.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03194971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 19, 2017)
Differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence using pathological assessment. [ Time Frame: Through completion of study, an average of four years. ]
Tissue samples will be obtained at autopsy. Pathological assessment of of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy
Official Title NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy
Brief Summary This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.
Detailed Description

RATIONALE:

Optune therapy with tumor treatment fields (TTFields) has recently been FDA approved for the treatment of newly diagnosed glioblastoma due to a recent clinical trial that showed improvement in progression free survival and overall survival compared to standard therapy. (1) TTFields also have a role in the recurrent glioblastoma treatment where it has demonstrated equal efficacy to second-line chemotherapy also has been shown to tumor progression and improve overall survival.(2) Though preclinical studies are ongoing, glioblastoma patients who have undergone TTField therapy have not yet been assessed at autopsy to determine both the pathological signature of TTField treatment, and the pattern of failure. This study will determine how the underlying pathological signatures of tumors treated with TTFields differ from those naïve to TTFields by comparing tumor tissue at autopsy.

STUDY:

All patients undergoing TTField therapy for newly diagnosed and recurrent glioblastoma will be considered for inclusion for this study. The investigators expect to enroll five patients per year for four years, totaling 10 patients treated upfront and 10 patients treated at tumor recurrence. An objective of this study is to determine differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Samples are obtained from regions suspicious for tumor.
Sampling Method Non-Probability Sample
Study Population Newly Diagnosed Glioblastoma Patients undergoing standard of care treatment consisting of surgery followed by chemo-radiation therapy will have the addition of Optune TTField therapy together with adjuvant chemotherapy. OR Recurrent Glioblastoma Patients with glioblastoma tumor recurrence defined by either imaging criteria, or deteriorating neurological function will be offered Optune TTField treatment at the discretion of the neurooncologist.
Condition Glioblastoma
Intervention
  • Other: Tumor samples from patients treated with TTFields at initial diagnosis.
    Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.
  • Other: Tumor samples from patients treated with TTFields at tumor recurrence.
    Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.
Study Groups/Cohorts
  • TTField at Recurrence
    Interventions:
    • Other: Tumor samples from patients treated with TTFields at initial diagnosis.
    • Other: Tumor samples from patients treated with TTFields at tumor recurrence.
  • TTField at New Diagnosis
    Interventions:
    • Other: Tumor samples from patients treated with TTFields at initial diagnosis.
    • Other: Tumor samples from patients treated with TTFields at tumor recurrence.
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: June 19, 2017)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2022
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed glioblastoma, WHO grade IV, patients undergoing TTField therapy.
  • Recurrent glioblastoma WHO grade IV, patients undergoing TTField therapy.

Exclusion Criteria:

  • TTField compliance < 75%.
  • Any contraindication to Optune TTField treatment.
  • Initial brain tumor diagnosis < WHO grade IV.
  • Duration of TTField therapy < 3 months.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03194971
Other Study ID Numbers PRO00017446
Has Data Monitoring Committee No
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: No
Responsible Party Peter LaViolette, Medical College of Wisconsin
Study Sponsor Medical College of Wisconsin
Collaborators Not Provided
Investigators
Principal Investigator: Peter LaViolette, PhD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date November 2019