Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials

NCT05706974 | Not Yet Recruiting

• 1 other identifier: 81185723
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative. The goal is to identify the obstacles and challenges that prevent participation in bile duct cancer clinical trials, as well as the reasons for withdrawal or discontinuation. The insights gained from this study will ultimately benefit those with bile duct cancer who may be invited to participate in medical research in the years to come.

Conditions

Bile Duct Cancer

Keywords

bile duct; bile duct cancer

Outcome Measures

Primary Outcomes (2)

• Number of bile duct cancer patients who decide to enroll in a clinical study

  3 months

• Rate of bile duct cancer patients who remain in a clinical study to 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

Bile duct cancer patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.

You may qualify if:

• Age ≥ 18 years
• Signed written informed consent
• Patient has been diagnosed with bile duct cancer

You may not qualify if:

• Woman pregnant or susceptible to the being
• Inability to perform regular electronic reporting

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Norton RA, Foster EA. Bile duct cancer. CA Cancer J Clin. 1990 Jul-Aug;40(4):225-33. doi: 10.3322/canjclin.40.4.225.

  PMID: 2114201 BACKGROUND

• Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. doi: 10.1002/bjs.10776.

  PMID: 29405274 BACKGROUND

• Xiang YJ, Sun JX, Wu JY, Wang K, Feng JK, Wei YG, Zhou JY, Zhang ZB, Zhang YQ, Qin YY, Yan ML, Cheng SQ. Recurrence hazard rate in patients with hepatocellular carcinoma and bile duct tumor thrombus: a multicenter observational study. HPB (Oxford). 2022 Oct;24(10):1703-1710. doi: 10.1016/j.hpb.2022.04.007. Epub 2022 Apr 22.

  PMID: 35523655 BACKGROUND

MeSH Terms

Conditions

Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; 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 20, 2023
• First Posted: January 31, 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