Clinical trial NCT05958485: A Close Examination of Patient Experiences in Glioblastoma Multiforme Clinical Research
Official title: Glioblastoma Multiforme Patients in Clinical Trials: An Examination of Their Clinical Trial Experiences
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma Multiforme
Keywords: glioblastoma multiforme
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: Patients with glioblastoma multiforme who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of glioblastoma multiforme
* No prior treatment for glioblastoma multiforme
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Female patients who are currently pregnant or nursing
* Enrolled in another research study
* Patients who are currently receiving any other investigational drug.

Primary outcomes:
measure: Rate of patients who decide to enroll in a glioblastoma multiforme clinical study.
timeFrame: 3 months
measure: Number of glioblastoma multiforme study participants who remain in clinical trial 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: 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.
citation: Tosoni 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.
citation: Ruda 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.