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Completed

NCT Number: NCT03194971

NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumor samples from patients treated with TTFields at initial diagnosis.

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.

Tumor samples from patients treated with TTFields at tumor recurrence.

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.

Primary outcomes

  1. Number of mitotically active cells

    Time frame: At baseline

    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.

  2. Number of mitotically inactive cells

    Time frame: At baseline

    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.

  3. Mitotic Ratio

    Time frame: At baseline

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

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2017
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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