Clinical trial NCT05694845: Evaluation of the Patient's Experience in Medical Studies for Cholangiocarcinoma
Official title: A Clinical Study Experiences of Cholangiocarcinoma Patients To Identify Trial Attributes Affecting Completion Rates For Specific Demographic Groups
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholangiocarcinoma
Keywords: Cholangiocarcinoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cholangiocarcinoma patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Brief summary: 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.

The 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. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future cholangiocarcinoma patients during clinical trials.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients who decide to enroll in a Cholangiocarcinoma Clinical Study.
timeFrame: 3 months
measure: Number of Cholangiocarcinoma patients who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Ilyas SI, 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.