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NCT Number: NCT06625684

Key Longitudinal Associations With Risk and Glioblastoma Outcomes

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.

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Key information

Conditions

Glioblastoma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Quinn Ostrom, PhD

CONTACT

[email protected]

919-684-5301

Quinn Ostrom, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Quinn Ostrom, PhD

CONTACT

[email protected]

919 -684-5301

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Glioblastoma Research Organization
  • StacheStrong

Registry information

Acronym: Key LARGO

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 3, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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