GlioblastomaKey LARGONCT06625684
Key Longitudinal Associations With Risk and Glioblastoma Outcomes
An observational study of Glioblastoma, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 10 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Those who cannot read either English or Spanish
- Those who cannot view an online survey
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Quinn Ostrom, PhD, 919-684-5301, gbmsurvey@duke.edu
Quinn Ostrom, PhD
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Glioblastoma, Genetic Predisposition to Disease, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
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
Measured: From date of enrollment until date of death from any cause as submitted by caregiver, up to 60 months
Functional Well-being as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire
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.
Measured: At time of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start10 Dec 2024
- Primary completion10 Dec 2029 (estimated)
- Study completion10 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Glioblastoma Research Organization, StacheStrong
- Responsible party
- Sponsor
- Investigators
- Quinn Ostrom, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625684
- Sponsor's protocol ID
- Pro00114859
- Acronym
- Key LARGO
- Status last verified
- Jan 2026
- First submitted
- 25 Sep 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Longitudinal Associations With Risk and Glioblastoma Outcomes
- ClinicalTrials.gov ID
- NCT06625684
- Acronym / sponsor ID
- Key LARGO / Pro00114859
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, genetic predisposition to disease, risk factors, quality of life, questionnaires, blood sample, adult brain cancer, observational study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Glioblastoma Research Organization, StacheStrong
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Dec 2029 (estimated)
- Study completion
- 10 Dec 2029 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Those who cannot read either English or Spanish
- Those who cannot view an online survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quinn Ostrom, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quinn Ostrom, PhD (919 -684-5301, GBMsurvey@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of enrollment until date of death from any cause as submitted by caregiver, up to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.