[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06625684":3,"trial-entities:NCT06625684":93,"trial-summary:NCT06625684":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":38,"interventions":41,"primary_outcomes":42,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":36,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":65,"locations":68,"central_contacts":85,"overall_officials":89,"references":91,"see_also_links":92},"NCT06625684","Pro00114859","Key Longitudinal Associations With Risk and Glioblastoma Outcomes","RECRUITING","2029-12-10","2026-01","2026-01-20","2024-12-10","Duke University","OTHER",true,"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.\n\nThe main questions it aims to answer are:\n\n* How do genetic and immune system factors impact survival and quality of life in GBM patients?\n* What occupational and medical history factors are linked to the risk of getting GBM?\n\nParticipants will:\n\n* Fill out an online survey about their medical history and lifestyle.\n\nParticipants 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.","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.\n\nThe 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.\n\nFindings 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.",[18],"Glioblastoma",[18,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34],"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","OBSERVATIONAL",null,[],{"count":39,"type":40},200,"ESTIMATED",[],[43,47],{"measure":44,"description":45,"timeFrame":46},"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","From date of enrollment until date of death from any cause as submitted by caregiver, up to 60 months",{"measure":48,"description":49,"timeFrame":50},"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.","At time of study enrollment",[],"ALL","18 Years",false,{"inclusion":56,"exclusion":61,"raw_text":64},[57,58,59,60],"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",[62,63],"Those who cannot read either English or Spanish","Those who cannot view an online survey","Inclusion Criteria:\n\n* At least 18 years old\n* Pathologically-confirmed diagnosis of glioblastoma multiforme (GBM) or grade 4 brain tumor\n* Participant is accessible for follow-up (has a working email address)\n* Participant is willing and able to comply with the study requirements\n\nExclusion Criteria:\n\n* Those who cannot read either English or Spanish\n* Those who cannot view an online survey",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":12,"status":7,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":82},"Durham","North Carolina","27710","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Quinn Ostrom, PhD","CONTACT","919-684-5301","gbmsurvey@duke.edu",{"name":76,"role":81},"PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},35.99403,-78.89862,[86],{"name":76,"role":77,"phone":87,"email":88},"919 -684-5301","GBMsurvey@duke.edu",[90],{"name":76,"affiliation":12,"role":81},[],[],{"nct_id":4,"conditions":94,"biomarkers":95},[18],[],{"nct_id":4,"found":14,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an observational study planning to enroll 200 participants with glioblastoma. It follows participants over time to see how different factors affect their health outcomes.","completed","Observational Study on Glioblastoma Outcomes","This observational study aims to understand what factors affect the health and risks for adults diagnosed with glioblastoma (GBM), a serious type of brain cancer. Researchers want to learn how genetics, the immune system, and your medical and work history might impact your survival and quality of life. You can join if you are at least 18 years old, have a confirmed diagnosis of glioblastoma, and can complete an online survey. The study will measure how long you live (Overall Survival) and your well-being using a questionnaire. This study does not involve any new treatments; it focuses on gathering information to help improve care for glioblastoma patients.","Your overall survival will be tracked from enrollment until death, up to 60 months (5 years).",107,"You will fill out an online survey about your medical history and lifestyle. You will also have the option to provide a blood sample using a home collection kit.","Not stated in the trial record.",[],"v2"]