Glioblastoma MultiformeNCT05958485
A Close Examination of Patient Experiences in Glioblastoma Multiforme Clinical Research
An observational study of Glioblastoma Multiforme, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Clinical research can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- 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: Patients with glioblastoma multiforme who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.
Who may be able to join
- Diagnosis of glioblastoma multiforme
- No prior treatment for glioblastoma multiforme
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Female patients who are currently pregnant or nursing
- Enrolled in another research study
- Patients who are currently receiving any other investigational drug.
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: Glioblastoma Multiforme Patients in Clinical Trials: An Examination of Their Clinical Trial Experiences
Clinical research can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative.
The goal is to identify the obstacles and challenges that prevent participation in glioblastoma multiforme clinical study, as well as the reasons for withdrawal or discontinuation.
Insights gained from this study will ultimately benefit those with glioblastoma multiforme who may be invited to participate in clinical trial in the years to come.
- Conditions
- Glioblastoma Multiforme
- Keywords
- glioblastoma multiforme
- Medical subject headings
- Glioblastoma
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 glioblastoma multiforme clinical study.
Measured: 3 months
Number of glioblastoma multiforme study participants who remain in clinical trial 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 Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The 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 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
- NCT05958485
- Sponsor's protocol ID
- 82196870
- 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
Michaelsen SR, Christensen IJ, Grunnet K, Stockhausen MT, Broholm H, Kosteljanetz M, Poulsen HS. Clinical variables serve as prognostic factors in a model for survival from glioblastoma multiforme: an observational study of a cohort of consecutive non-selected patients from a single institution. BMC Cancer. 2013 Sep 3;13:402. doi: 10.1186/1471-2407-13-402.
PubMed 24004722Tosoni A, Gatto L, Franceschi E, Di Nunno V, Lodi R, Mura A, Di Battista M, Bartolini S, Brandes AA. Association between socioeconomic status and survival in glioblastoma: An Italian single-centre prospective observational study. Eur J Cancer. 2021 Mar;145:171-178. doi: 10.1016/j.ejca.2020.12.027. Epub 2021 Jan 22.
PubMed 33486440Ruda R, Bruno F, Pellerino A, Pronello E, Palmiero R, Bertero L, Crasto S, Polo V, Vitaliani R, Trincia E, Interno V, Porta C, Soffietti R. Observational real-life study on regorafenib in recurrent glioblastoma: does dose reduction reduce toxicity while maintaining the efficacy? J Neurooncol. 2022 Nov;160(2):389-402. doi: 10.1007/s11060-022-04155-9. Epub 2022 Oct 30.
PubMed 36309895
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
- Glioblastoma Multiforme Patients in Clinical Trials: An Examination of Their Clinical Trial Experiences
- ClinicalTrials.gov ID
- NCT05958485
- Acronym / sponsor ID
- 82196870
- Conditions
- Glioblastoma Multiforme
- Keywords
- glioblastoma multiforme
- 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.
Clinical research can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative.
The goal is to identify the obstacles and challenges that prevent participation in glioblastoma multiforme clinical study, as well as the reasons for withdrawal or discontinuation.
Insights gained from this study will ultimately benefit those with glioblastoma multiforme who may be invited to participate in clinical trial in the years to come.
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
- Patients with glioblastoma multiforme who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Diagnosis of glioblastoma multiforme
- No prior treatment for glioblastoma multiforme
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Female patients who are currently pregnant or nursing
- Enrolled in another research study
- Patients who are currently receiving any other investigational drug.
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 glioblastoma multiforme clinical study.
Time frame: 3 months
Number of glioblastoma multiforme study participants who remain in clinical trial 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 24004722Michaelsen SR, Christensen IJ, Grunnet K, Stockhausen MT, Broholm H, Kosteljanetz M, Poulsen HS. Clinical variables serve as prognostic factors in a model for survival from glioblastoma multiforme: an observational study of a cohort of consecutive non-selected patients from a single institution. BMC Cancer. 2013 Sep 3;13:402. doi: 10.1186/1471-2407-13-402.
- Background: PubMed 33486440Tosoni A, Gatto L, Franceschi E, Di Nunno V, Lodi R, Mura A, Di Battista M, Bartolini S, Brandes AA. Association between socioeconomic status and survival in glioblastoma: An Italian single-centre prospective observational study. Eur J Cancer. 2021 Mar;145:171-178. doi: 10.1016/j.ejca.2020.12.027. Epub 2021 Jan 22.
- Background: PubMed 36309895Ruda R, Bruno F, Pellerino A, Pronello E, Palmiero R, Bertero L, Crasto S, Polo V, Vitaliani R, Trincia E, Interno V, Porta C, Soffietti R. Observational real-life study on regorafenib in recurrent glioblastoma: does dose reduction reduce toxicity while maintaining the efficacy? J Neurooncol. 2022 Nov;160(2):389-402. doi: 10.1007/s11060-022-04155-9. Epub 2022 Oct 30.
- 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 Glioblastoma Multiforme, 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 glioblastoma multiforme clinical study. (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 NCT05958485, 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.