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Assessing Medical Trial Experiences of Hairy Cell Leukemia Patients

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05859932
Collaborator
(none)
500
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.

This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for hairy cell leukemia.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of hairy cell leukemia studies.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    A Look at the Patterns in Clinical Research Participation Among Patients With Hairy Cell Leukemia
    Anticipated Study Start Date :
    Jun 1, 2024
    Anticipated Primary Completion Date :
    Jun 1, 2025
    Anticipated Study Completion Date :
    Jun 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patients who decide to enroll in a hairy cell leukemia clinical study. [3 months]

    2. Number of hairy cell leukemia 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:

    • Aged ≥ 18 years old

    • Ability to understand and the willingness to sign a written informed consent document.

    • Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

    Exclusion Criteria:

    • Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study

    • Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial

    • Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

    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:
    NCT05859932
    Other Study ID Numbers:
    • 81405664
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    May 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.
    hairy cell leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Hairy Cell

    Study Results

    No Results Posted as of May 16, 2023