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

NCT ID: NCT05694845

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cholangiocarcinoma

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

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Michael B Gill

Role: CONTACT

415-900-4227

References

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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.

Reference Type BACKGROUND
PMID: 21808282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33683644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28994423 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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82275501

Identifier Type: -

Identifier Source: org_study_id

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