Clinical trial NCT05958472: Navigating the Clinical Research Process for Glioma
Official title: Study on Glioma Patients: Understanding Their Glioma Clinical Trial Experiences
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioma
Keywords: glioma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Glioma patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of glioma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future glioma patients.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of glioma
* Participant must be 18 years of age or older
* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Participant is actively receiving study therapy in another
* Inability to provide written informed consent

Primary outcomes:
measure: Rate of patients who decide to enroll in a glioma clinical research.
timeFrame: 3 months
measure: Number of glioma study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: van der Meer PB, Dirven L, Fiocco M, Vos MJ, Kouwenhoven MCM, van den Bent MJ, Taphoorn MJB, Koekkoek JAF. Effectiveness of Antiseizure Medication Duotherapies in Patients With Glioma: A Multicenter Observational Cohort Study. Neurology. 2022 Sep 6;99(10):e999-e1008. doi: 10.1212/WNL.0000000000200807. Epub 2022 Jun 8.
citation: Epstein RH, Dexter F, Cajigas I, Mahavadi AK, Shah AH, Abitbol N, Komotar RJ. Prolonged tracheal extubation time after glioma surgery was associated with lack of familiarity between the anesthesia provider and the operating neurosurgeon. A retrospective, observational study. J Clin Anesth. 2020 Mar;60:118-124. doi: 10.1016/j.jclinane.2019.09.003. Epub 2019 Oct 24.
citation: Berntsson SG, Merrell RT, Amirian ES, Armstrong GN, Lachance D, Smits A, Zhou R, Jacobs DI, Wrensch MR, Olson SH, Il'yasova D, Claus EB, Barnholtz-Sloan JS, Schildkraut J, Sadetzki S, Johansen C, Houlston RS, Jenkins RB, Bernstein JL, Lai R, Shete S, Amos CI, Bondy ML, Melin BS. Glioma-related seizures in relation to histopathological subtypes: a report from the glioma international case-control study. J Neurol. 2018 Jun;265(6):1432-1442. doi: 10.1007/s00415-018-8857-0. Epub 2018 Apr 23.