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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Bile duct cancer patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Gill | Contact | 4159004227 | bask@withpower.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael B Gill | Power Life Sciences Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2114201 | Background | 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. | |
| 29405274 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2023 | Jan 20, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 35523655 | 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. |
| D001649 |
| Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |