GliomaNCT05958472
Navigating the Clinical Research Process for Glioma
An observational study of Glioma, run by Power Life Sciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Glioma patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating woman
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Study on Glioma Patients: Understanding Their Glioma Clinical Trial Experiences
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.
- Conditions
- Glioma
- Keywords
- glioma
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a glioma clinical research.
Measured: 3 months
Number of glioma study participants who remain in clinical study until completion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958472
- Sponsor's protocol ID
- 81932689
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36219797Epstein 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.
PubMed 31669746Berntsson 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.
PubMed 29687214
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Glioma Patients: Understanding Their Glioma Clinical Trial Experiences
- ClinicalTrials.gov ID
- NCT05958472
- Acronym / sponsor ID
- 81932689
- Conditions
- Glioma
- Keywords
- glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Jul 2023 (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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glioma patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or lactating woman
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
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
Rate of patients who decide to enroll in a glioma clinical research.
Time frame: 3 months
Number of glioma study participants who remain in clinical study until completion.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 36219797van 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.
- Background: PubMed 31669746Epstein 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.
- Background: PubMed 29687214Berntsson 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
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 Glioma, run by Power Life Sciences Inc. 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a glioma clinical research. (time frame: 3 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?
On the ClinicalTrials.gov record for NCT05958472, which also lists 3 linked publications.
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 24 Jul 2023.