Evaluation of the Patient’s Experience in Medical Studies for Cholangiocarcinoma

Overview

The main reason for conducting this research is to gain a better understanding of why some people with cholangiocarcinoma are not able to participate in or complete clinical trials. Historically, certain groups of people have been more likely to participate in clinical trials, but there hasn't been much research to understand why this is the case. Our goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. We will look at this data through different demographic lenses and identify trends that could help improve the experience of future cholangiocarcinoma patients during clinical trials.

Full Title of Study: “Extensive Clinical Study Experiences of Cholangiocarcinoma Patients To Identify Trial Attributes Affecting Completion Rates For Specific Demographic Groups”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 12, 2024

Clinical Trial Outcome Measures

Primary Measures

  • Rate of patients who decide to enroll in a Cholangiocarcinoma Clinical Study.
    • Time Frame: 3 months
  • Number of Cholangiocarcinoma patients who remain in clinical trial until completion.
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is at least 18 years of age – Participant has a diagnosis of Cholangiocarcinoma – Patient has self-identified as planning to enroll in an interventional Cholangiocarcinoma clinical trial – Patient must provide written informed consent Exclusion Criteria:

  • No diagnosis of Cholangiocarcinoma confirmed – Inability to perform regular electronic reporting – Women who are pregnant, intend to become pregnant, or are lactating – Patient does not understand, sign, and return consent form

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Power Life Sciences Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael B Gill, Study Director, Power Life Sciences Inc.
  • Overall Contact(s)
    • Michael B Gill, 415-900-4227, bask@withpower.com

References

Blechacz B, Komuta M, Roskams T, Gores GJ. Clinical diagnosis and staging of cholangiocarcinoma. Nat Rev Gastroenterol Hepatol. 2011 Aug 2;8(9):512-22. doi: 10.1038/nrgastro.2011.131.

Garcia-Pardo M, Ortega L, Fernandez-Acenero MJ, Garcia Alfonso P, Martin M, Munoz AJ. Molecular Profiling and Targeted Therapy in Cholangiocarcinoma: An Observational, Retrospective Multicenter Study. J Gastrointest Cancer. 2021 Jun;52(2):814-818. doi: 10.1007/s12029-021-00622-0. Epub 2021 Mar 8.

Rizvi S, Khan SA, Hallemeier CL, Kelley RK, Gores GJ. Cholangiocarcinoma – evolving concepts and therapeutic strategies. Nat Rev Clin Oncol. 2018 Feb;15(2):95-111. doi: 10.1038/nrclinonc.2017.157. Epub 2017 Oct 10.

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