Key Longitudinal Associations With Risk and Glioblastoma Outcomes

Recruiting

• Conditions: Glioblastoma

• Registration Number: NCT06625684
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2024-12-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2029-12-10
• Study Completion: 2029-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	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	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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States