NCT03954691

Brief Summary

The investigators want to verify the hypothesis that targeting the calcium-activated (KCa3.1) and the voltage-dependent K channel (Kv1.3) could be a valuable therapeutic strategy to reprogram cells of the innate immune system, with the aim to fight glioma, a deadly CNS tumor. The investigators will use murine models of glioma, injecting GL261 cells in the brain of syngeneic C57BL6 mice, to study the effect of K channel inhibition on the activation of microglia (M), macrophages (Mf) and NK cells. The investigators will use M and vesicles released from these cells, re-educated toward an anti-tumor phenotype, to interfere with the vicious circle responsible of uncontrolled tumor growth and will study the role of NK cells in tumor-M/Mf communication. The investigators will also investigate how K channels interfere with the communication of innate immune cells and brain cells like neurons and astrocytes, with experiments focused on synaptic transmission and calcium imaging, investigating the effect of modulation of the tumor microenvironment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 11, 2019

Last Update Submit

May 17, 2019

Conditions

Cancer of Head and Neck

Outcome Measures

Primary Outcomes (1)

  • glioblastoma cells

    observational studies on cells isolated from tumor specimens

    6 months

Interventions

brain tumor-immune cells communicationOTHER

tumoral and immune cell isolation from biopsis

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

glioma patients who undergo neurosurgery for glioblastoma surgical eradication

You may qualify if:

  • \- glioma patients who undergo neurosurgery

You may not qualify if:

  • \- biopsies from patients with brain tumor different than glioma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cristina Limatola

Pozzilli, Is, 86007, Italy

Location

Cristina Limatola

Pozzilli, 86077, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

glioblastoma biopsies

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Cristina Limatola, PhD

CONTACT

+390865915217cristina.limatola@uniroma1.it

Study Design

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

Study Record Dates

First Submitted

May 11, 2019

First Posted

May 17, 2019

Study Start

October 1, 2019

Primary Completion

April 1, 2020

Study Completion

October 1, 2021

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

IT(2)