Clinical trial for Glioma
Official title A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma, GHoST Trial
ClinicalTrials.gov ID: NCT07074756
What this study is testing
What is Chemotherapy?
An investigational chemotherapy being studied for glioma.
Also referred to as Chemo.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how well the digital platform works for delivering treatment at home.
- Who it's for
- It is looking for patients who have glioma, including recurrent glioma or glioblastoma.
- What's involved
- Participants will use a mobile application that lets them stay in touch with their neuro‑oncology care team from home.
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.