Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05706974
Collaborator
(none)
500
24

Study Details

Study Description

Brief Summary

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in bile duct cancer clinical trials, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with bile duct cancer who may be invited to participate in medical research 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:
    Prospective Evaluation of Clinical Study Experiences of Patients With Bile Duct Cancer
    Anticipated Study Start Date :
    Feb 20, 2023
    Anticipated Primary Completion Date :
    Feb 20, 2024
    Anticipated Study Completion Date :
    Feb 20, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Number of bile duct cancer patients who decide to enroll in a clinical study [3 months]

    2. Rate of bile duct cancer patients who remain in a clinical study to 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:
    • Age ≥ 18 years

    • Signed written informed consent

    • Patient has been diagnosed with bile duct cancer

    Exclusion Criteria:
    • Woman pregnant or susceptible to the being

    • Inability to perform regular electronic reporting

    • Inclusion in another investigational clinical trial

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT05706974
    Other Study ID Numbers:
    • 81185723
    First Posted:
    Jan 31, 2023
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Jan 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 Jan 31, 2023