NCT06625684 · Duke University
Key Longitudinal Associations With Risk and Glioblastoma Outcomes
(Key LARGO)
What this study is about
The goal of this observational study is to find out what factors affect the health and risks in adults with glioblastoma (GBM), a grade 4 brain cancer.
View original scientific description
The goal of this observational study is to find out what factors affect the health and risks in adults with glioblastoma (GBM), a grade 4 brain cancer. The main questions it aims to answer are: * How do genetic and immune system factors impact survival and quality of life in GBM patients? * What occupational and medical history factors are linked to the risk of getting GBM? Participants will: * Fill out an online survey about their medical history and lifestyle. Participants will have the chance to give a blood sample (from the outer arm) for genetic and immune system testing. Blood samples will be given using a home collection kit provided by the study team.
Primary outcome measures
Overall Survival
Time frame: From date of enrollment until date of death from any cause as submitted by caregiver, up to 60 months
Overall survival will be estimated using patient-reported date of diagnosis and assessed in three month intervals until patients are reported as deceased or are lost to follow-up
Functional Well-being as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire
Time frame: At time of study enrollment
Estimated using the functional well-being subscale of the FACT-Br questionnaire. The score ranges from 0 to 28, where a higher score indicates greater functional well-being.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At least 18 years old
- Pathologically-confirmed diagnosis of glioblastoma multiforme (GBM) or grade 4 brain tumor
- Participant is accessible for follow-up (has a working email address)
- Participant is willing and able to comply with the study requirements
Exclusion criteria
- Those who cannot read either English or Spanish
- Those who cannot view an online survey
Where
- Durham, North Carolina
Collaborators
Glioblastoma Research Organization, StacheStrong
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations