NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

NCT03194971 | Completed FDA Device

• 1 other identifier: PRO00017446
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

glioblastoma; brain tumor autopsy; autopsy; Optune therapy; tumor treatment fields; TTFields; Recurrent glioblastoma; grade IV; brain tumor; newly diagnosed glioblastoma

Outcome Measures

Primary Outcomes (3)

• Number of mitotically active cells

  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.

  At baseline

• Number of mitotically inactive cells

  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.

  At baseline

• Mitotic Ratio

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

  At baseline

Study Arms (2)

TTField at Recurrence

Device: Tumor samples from patients treated with TTFields at tumor recurrence.

TTField at New Diagnosis

Other: Tumor samples from patients treated with TTFields at initial diagnosis.

Interventions

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.

TTField at New Diagnosis

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.

TTField at Recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Newly diagnosed glioblastoma, World Health Organization (WHO) grade IV, patients undergoing TTField therapy.
• Recurrent glioblastoma WHO grade IV, patients undergoing TTField therapy.

You may not qualify if:

• TTField compliance \< 75%.
• Any contraindication to Optune TTField treatment.
• Initial brain tumor diagnosis \< WHO grade IV.
• Duration of TTField therapy \< 3 months.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples are obtained from regions suspicious for tumor at autopsy.

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Peter LaViolette, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 21, 2017
• Study Start: June 1, 2017
• Primary Completion: June 4, 2023
• Study Completion: June 4, 2023
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)