NCT05556486

Brief Summary

The study investigates the occurance of GlioStem positive tumor stem cells in the rescection marigins of hig grade human gliomas

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 5, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

September 22, 2022

Last Update Submit

September 22, 2022

Conditions

Glioma, Malignant

Outcome Measures

Primary Outcomes (1)

  • GlioStem frequency

    Frequency of GlioStem positive tumor cells in marigin of tumor compared to outside resection marigin.

    May 2025

Secondary Outcomes (1)

  • GlioStem genetic

    May 2025

Interventions

GlioStemDEVICE

GlioStem is an oligothiophene derivative which can penetrate physiological cell membranes and selectively binds to structures inside the GSCs. GlioStem is conveniently administered ex-vivo onto the investigated tissue or cell culture by a pipette. After only a few minutes, the GSCs will emit green light from GlioStem molecules under blue illumination.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Adult patient operatied for high grade gliomas at Department of Neurosurgery, Karolinska University Hospital, Sweden.

You may qualify if:

  • Operation for high grade malignat glioma (novel or recurrence)

You may not qualify if:

  • Unable to provide informed consent
  • Insufficent tissue material to allow GlioStem analysis while not compromising histopathological analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Microbiopsies from high grade glial tumors and tumor periphery

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Oscar Persson, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Persson, MD, PhD

CONTACT

+460812370000oscar.persson@regionstockholm.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neurosurgeon

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 27, 2022

Study Start

May 5, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)