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

NCT05694845 | Not Yet Recruiting

• 1 other identifier: 82275501
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a Cholangiocarcinoma Clinical Study.

  3 months

• Number of Cholangiocarcinoma patients who remain in clinical trial until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related 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.

  PMID: 21808282 BACKGROUND

• 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.

  PMID: 33683644 BACKGROUND

• 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.

  PMID: 28994423 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 6, 2023

Record last verified: 2023-01