A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

March 17, 2020 updated by: Doo-Sik Kong

A Clinical Study to Explore the Feasibility of AVATAMED in Predicting the Cilnical Response to Temozolomide in Glioblastoma Patients, a Single-center, Prospective Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled.

Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. contraindication to TMZ
  2. prior anti-cancer therapy except standard of care (*standard of care includes surgery, Stupp regimen, and radiotherapy)
  3. uncontrolled systemic medical illness
  4. pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 month PFS rate
Time Frame: 6 month
the fraction of patients without disease progression at 6 months after the TMZ treatment
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doo-Sik Kong

Investigators

  • Principal Investigator: Doo-sik Kong, MD PhD, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-12-071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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