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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05706974
Other study ID # 81185723
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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: - Age = 18 years - Signed written informed consent - Patient has been diagnosed with bile duct cancer Exclusion Criteria: - Woman pregnant or susceptible to the being - Inability to perform regular electronic reporting - Inclusion in another investigational clinical trial

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of bile duct cancer patients who decide to enroll in a clinical study 3 months
Primary Rate of bile duct cancer patients who remain in a clinical study to completion 12 months
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