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Digital Treatment Platform for Glioma Home-Based Therapy

This study is testing a digital platform, including a mobile app, to help manage chemotherapy for people with glioma (a type of brain tumor) at home. The goal is to make it easier for patients to get specialized care, especially if they live far from a treatment center or have other challenges. You would receive standard chemotherapy and use the digital platform for remote management and monitoring. Researchers want to see if this platform is practical to use and if it helps patients stick to their treatment plans. They will also look at how well the treatments work and if the platform is safe and acceptable to patients. This study is for adults aged 18 and older who have been diagnosed with glioma and are planning to receive chemotherapy for at least six months.

Study design
This is an interventional study planning to enroll 120 participants. It is testing a digital platform alongside standard chemotherapy.
What's involved
You would undergo CT scans, MRI scans, and neurologic examinations, in addition to receiving standard chemotherapy and using the remote monitoring platform. The primary goal is to assess feasibility through study visits over 6 months (26 weeks).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures feasibility through study visits up to 6 months (26 weeks) after baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07074756

A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma, GHoST Trial

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~202 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:ChemotherapyComputed TomographyInternet-Based InterventionMagnetic Resonance ImagingNeurologic ExaminationQuestionnaire Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility - completion of study visits
Measured over At baseline and the set of study-specific visits through 6 months (i.e., 26 weeks ± 2 weeks)
+1 more outcome measured

Conditions

Glioma
Recurrent Glioma
Recurrent Glioblastoma

Explore related trials

Glioma

Where it's being run

2 sites across 2 states
Florida1
Minnesota1

Study leadership

  • Ugur T. Sener, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Diagnosis of glioma and intention to treat with either new or ongoing systemic therapy for at least 6 months.
NOTE: Patient may be enrolled following completion of surgery and/or radiation therapy for newly diagnosed or recurrent tumor.
NOTE: Any number of prior recurrences is permitted
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60
Expected survival ≥ 6 months in the opinion of treatment team
Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations
Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
Exception: Not required if patient is already on treatment. May be obtained prior to next treatment as needed per clinical care
Provide written informed consent
Ability to complete assessments and questionnaires by themselves or with assistance
SUBSTUDY 1: Enrolled in GHoST Master Protocol per eligibility criteria of the master study and clinically appropriate to proceed with bevacizumab treatment at the discretion of the treating physician
SUBSTUDY 1: Diagnosis of recurrent glioblastoma and intention to treat with bevacizumab
NOTE: Any number of prior recurrences is permitted
NOTE: Prior limited use of bevacizumab for radiation necrosis/treatment related edema is permitted. Prior use should not exceed four infusions with the last dose administered ≥ 4 weeks prior to enrollment in this substudy
SUBSTUDY 1: Willing and able to adhere to the substudy for the duration of the substudy including undergoing treatment, and attending scheduled visits, and examinations
SUBSTUDY 1: Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
SUBSTUDY 1: Provide written informed consent
SUBSTUDY 1: Ability to complete assessments and questionnaires by themselves or with assistance

Exclusion

Pregnant or nursing, imprisoned, or lacking capacity for understanding
Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
SUBSTUDY 1: Pregnant or nursing, imprisoned, or lacking capacity for understanding
SUBSTUDY 1: Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings

What this trial measures

  • Feasibility - completion of study visitsAt baseline and the set of study-specific visits through 6 months (i.e., 26 weeks ± 2 weeks)

    Feasibility will be assessed by the number of study visits completed vs. not. Will consider this to be feasible in this patient population if the true compliance rate is at least 60%. Compliance here is defined as completion of at least 4 disease assessment timepoints in the first 6 months on study (i.e. 26 ± 2 weeks). These assessment timepoints will include the baseline assessment and can include assessments after 2 cycles of therapy, after 4 cycles of therapy, after 6 cycles of therapy, dependent on the treatment-specific schedules.

  • 4-month progression-free survival (PFS) rate (Subprotocol 1)Up to 4 months after beginning study therapy

    Defined as the number of patients who are alive and progression-free at least 4 months after beginning study therapy. A point estimate will be generated for 4-month PFS rate.