Clinical trial NCT06625684: Key Longitudinal Associations With Risk and Glioblastoma Outcomes
Official title: Key Longitudinal Associations With Risk and Glioblastoma Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma
Keywords: Glioblastoma
genetic predisposition to disease
risk factors
quality of life
questionnaires
blood sample
adult brain cancer
observational study
personal medical history
survival outcomes
cancer epidemiology
genetics, medical
immunologic factors
patient outcomes
health history
occupational exposure
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Glioblastoma Research Organization
name: StacheStrong
First posted: 2024-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit glioblastoma (GBM) patients from the general population through social media and email listservs. Recruitment efforts will be supported by GBMRO, StacheStrong, and the Duke Preston Robert Tisch Brain Tumor Center. These organizations will disseminate study information via electronic communications to their GBM patient listservs and promote the study on social media platforms such as Facebook and Twitter. The study aims to enroll a diverse population of GBM patients from around the world, ensuring broad representation across various demographics and regions.

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Overall Survival
timeFrame: From date of enrollment until date of death from any cause as submitted by caregiver, up to 60 months
measure: Functional Well-being as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire
timeFrame: At time of study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kyle M Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: