CompletedNot Applicable

Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas

United States20 participantsStarted 2012-07-13

Plain-language summary

The primary goal of this study is evaluate T cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed HGGs undergoing the standard RT/TMZ and adjuvant TMZ.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients must be at least 18 years of age.
. Patients must have histologically confirmed new diagnosed high grade glioma by pathology (WHO grade III and IV).
. Patients proposed post-operative treatment plan must include standard radiation and temozolomide.
. Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
. Patients must be able to provide written informed consent.
. Steroid use is allowed.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in T Cell subtypes and cytokines as a function of treatment

Timeframe: 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ

Trial details

NCT IDNCT02041611

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09-02

View on ClinicalTrials.gov More High Grade Glioma trials