NCT04313842

Brief Summary

This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.

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 Jul 2019

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

July 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 17, 2020

Last Update Submit

March 17, 2020

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • 6 month PFS rate

    the fraction of patients without disease progression at 6 months after the TMZ treatment

    6 month

Interventions

AVATAMEDDEVICE

tumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

among histologically confirmed glioblastoma patients, patients with samples which passed the QC screening process of in vitro drug screening experiment will be finally enrolled.

You may qualify if:

  • written informed consent
  • histologically confirmed glioblastoma patients who will take TMZ treatment
  • KPS \>70
  • adequte end-organ function
  • prior major surgery \> 4 weeks (prior minor surgery \> 1weeks)
  • prior standard concurrent chemo-radiation therapy \> 4 weeks
  • prior radiation therapy (including stereotactic radiosurgery) \> 12 weeks

You may not qualify if:

  • contraindication to TMZ
  • prior anti-cancer therapy except standard of care (\*standard of care includes surgery, Stupp regimen, and radiotherapy)
  • uncontrolled systemic medical illness
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Doo-sik Kong, MD PhD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doo-sik Kong, MD PhD

CONTACT

82-2-6182-5036doosik.kong@samsung.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 18, 2020

Study Start

July 1, 2019

Primary Completion

June 1, 2021

Study Completion

January 1, 2022

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

KR(1)