A Close Examination of Patient Experiences in Glioblastoma Multiforme Clinical Research

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05958485
Collaborator
(none)
500
1
24
20.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Glioblastoma Multiforme Patients in Clinical Trials: An Examination of Their Clinical Trial Experiences
    Anticipated Study Start Date :
    Aug 1, 2024
    Anticipated Primary Completion Date :
    Aug 1, 2025
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patients who decide to enroll in a glioblastoma multiforme clinical study. [3 months]

    2. Number of glioblastoma multiforme study participants who remain in clinical trial until completion. [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Power Life Sciences San Francisco California United States 94107

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05958485
    Other Study ID Numbers:
    • 82196870
    First Posted:
    Jul 24, 2023
    Last Update Posted:
    Jul 24, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 24, 2023