Key Longitudinal Associations With Risk and Glioblastoma Outcomes

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06625684
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Duke University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kyle M Walsh, PhD
Principal Investigator Affiliation	Duke University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

This observational study aims to investigate the various factors influencing outcomes and risks in adults diagnosed with glioblastoma (GBM). Glioblastoma is a highly aggressive and malignant brain tumor, and understanding the factors that affect patient outcomes is crucial for improving management strategies and patient care. The study employs a case-only design where participants will be followed over time to observe how different factors affect their health outcomes. Participants will be selected based on their diagnosis of glioblastoma and will be included in the study regardless of current treatment status or disease stage. Findings from this study are expected to provide valuable insights into the factors affecting glioblastoma outcomes and may contribute to the development of personalized treatment strategies and risk assessment tools for better management of the disease.

Arms & Interventions

Arms

: Adults with Glioblastoma

This group consists of adults diagnosed with glioblastoma, a type of aggressive brain tumor. Participants are observed to identify factors influencing their outcomes, including genetic, immunologic, and personal medical history factors. The study aims to explore how these factors impact survival rates and quality of life in this patient population. There are no specific interventions. Instead, the focus is on analyzing survey data and biological samples to understand risk factors and disease progression.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University, Durham, North Carolina

Status

Recruiting

Address

Duke University

Durham, North Carolina, 27710

Site Contact

Courtney E Wimberly, MSc

[email protected]

919-681-9609

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