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

Cholangiocarcinoma Clinical Trial

Official title:

A Clinical Study Experiences of Cholangiocarcinoma Patients To Identify Trial Attributes Affecting Completion Rates For Specific Demographic Groups

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05694845
• Other study ID #: 82275501
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: February 2026

Study information

• Verified date: January 2023
• Source: Power Life Sciences Inc.
• Contact: Michael B Gill
• Phone: 415-900-4227
• Email: bask[@]withpower.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Power Life Sciences Inc.

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who decide to enroll in a Cholangiocarcinoma Clinical Study.		3 months
Primary	Number of Cholangiocarcinoma patients who remain in clinical trial until completion.		12 months