Determining Patterns In Study Experiences of Neuroblastoma Patients

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05918432
Collaborator
(none)
500
1
24
20.8

Study Details

Study Description

Brief Summary

Historically, participation in clinical research is highly skewed towards particular demographic groups of people.

This study will invite several participants to gather a wide range of information on clinical trial experiences for neuroblastoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of neuroblastoma.

The data collected from this study will help improve future outcomes for all neuroblastoma patients as well as those in under-represented demographic groups.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Neuroblastoma Clinical Trials: Looking at Patterns About How Patients Feel About Participating in Clinical Trials
    Anticipated Study Start Date :
    Jul 1, 2024
    Anticipated Primary Completion Date :
    Jul 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who decide to enroll in a neuroblastoma clinical trial [3 months]

    2. Rate of patients who remain in neuroblastoma clinical trial to trial 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:
    • Confirmed diagnosis of neuroblastoma

    • Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    • Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

    Exclusion Criteria:
    • Women of childbearing potential without a negative pregnancy test; or women who are lactating.

    • Any serious and/or unstable pre-existing medical disorders

    • Enrolled in another research study

    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:
    NCT05918432
    Other Study ID Numbers:
    • 81920705
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 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 Jun 26, 2023