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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.

Tumor samples from patients treated with TTFields at initial diagnosis.

Tumor samples from patients treated with TTFields at tumor recurrence.

Medical College of Wisconsin Cancer Center Clinical Trials Office

Peter LaViolette

Peter LaViolette, PhD

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

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.

Samples are obtained from regions suspicious for tumor at autopsy.

NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of active cells will be counted computationally.

Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of not active cells will be counted computationally.

Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.

Medical College of Wisconsin

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy	NCT03194971	Glioblastoma	Tumor samples f... Tumor samples f...	18 Years -	Medical College of Wisconsin
NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy	NCT03194971	Glioblastoma	Tumor samples f... Tumor samples f...	18 Years -	Medical College of Wisconsin

Spots Global Cancer Trial Database for tumor samples from patients treated with ttfields at initial diagnosis.