NovoTTF Treatment Signatures in Glioblastoma Patients At Autopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2027-05-31

Brief Summary

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This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.

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Detailed Description

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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.

Conditions

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Glioblastoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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TTField at Recurrence

Tumor samples from patients treated with TTFields at tumor recurrence.

Intervention Type DEVICE

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.

TTField at New Diagnosis

Tumor samples from patients treated with TTFields at initial diagnosis.

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed glioblastoma, World Health Organization (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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No