Bile Duct CancerNCT05706974
Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials
An observational study of Bile Duct Cancer, run by Power Life Sciences Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Cancer
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bile duct cancer patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.
Who may be able to join
- Age ≥ 18 years
- Signed written informed consent
- Patient has been diagnosed with bile duct cancer
Who cannot join
- Woman pregnant or susceptible to the being
- Inability to perform regular electronic reporting
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Evaluation of Clinical Study Experiences of Patients With Bile Duct Cancer
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
- Medical subject headings
- Bile Duct Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bile duct cancer patients who decide to enroll in a clinical study
Measured: 3 months
Rate of bile duct cancer patients who remain in a clinical study to completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706974
- Sponsor's protocol ID
- 81185723
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 2114201Ebata 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.
PubMed 29405274Xiang 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.
PubMed 35523655
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Clinical Study Experiences of Patients With Bile Duct Cancer
- ClinicalTrials.gov ID
- NCT05706974
- Acronym / sponsor ID
- 81185723
- Conditions
- Bile Duct Cancer
- Keywords
- bile duct, bile duct cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bile duct cancer patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Signed written informed consent
- Patient has been diagnosed with bile duct cancer
Key exclusion criteria (2 listed)
- Woman pregnant or susceptible to the being
- Inability to perform regular electronic reporting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of bile duct cancer patients who decide to enroll in a clinical study
Time frame: 3 months
Rate of bile duct cancer patients who remain in a clinical study to completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 2114201Norton RA, Foster EA. Bile duct cancer. CA Cancer J Clin. 1990 Jul-Aug;40(4):225-33. doi: 10.3322/canjclin.40.4.225.
- Background: PubMed 29405274Ebata 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.
- Background: PubMed 35523655Xiang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Cancer, run by Power Life Sciences Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bile duct cancer patients who decide to enroll in a clinical study (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706974, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.