Hepatocellular CarcinomaNCT05859945
Navigating the Clinical Trial Process for Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, 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 study, both positive and negative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 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: Patients with hepatocellular carcinoma who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.
Who may be able to join
- Diagnosed with hepatocellular carcinoma
- Willing to comply with all study related procedures and assessments
- Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Who cannot join
- No documented diagnosis of hepatocellular carcinoma
- Any serious and/or unstable pre-existing medical disorders
- Pregnant or lactating woman
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Critical Analysis of Hepatocellular Carcinoma Trials: Perspectives From Patient Experiences
Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative.
The goal is to identify the obstacles and challenges that prevent participation in hepatocellular carcinoma clinical research, as well as the reasons for withdrawal or discontinuation.
Insights gained from this study will ultimately benefit those with hepatocellular carcinoma who may be invited to participate in clinical research in the years to come.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a hepatocellular carcinoma clinical study.
Measured: 3 months
Number of hepatocellular carcinoma study participants who remain in clinical trial until 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 posted16 May 2023
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 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 Hepatocellular CarcinomaStudies 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
- NCT05859945
- Sponsor's protocol ID
- 82127001
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Frenette C, Gish R. Targeted systemic therapies for hepatocellular carcinoma: clinical perspectives, challenges and implications. World J Gastroenterol. 2012 Feb 14;18(6):498-506. doi: 10.3748/wjg.v18.i6.498.
PubMed 22363115Haber PK, Puigvehi M, Castet F, Lourdusamy V, Montal R, Tabrizian P, Buckstein M, Kim E, Villanueva A, Schwartz M, Llovet JM. Evidence-Based Management of Hepatocellular Carcinoma: Systematic Review and Meta-analysis of Randomized Controlled Trials (2002-2020). Gastroenterology. 2021 Sep;161(3):879-898. doi: 10.1053/j.gastro.2021.06.008. Epub 2021 Jun 12.
PubMed 34126063Luo XY, Wu KM, He XX. Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets. J Exp Clin Cancer Res. 2021 May 18;40(1):172. doi: 10.1186/s13046-021-01968-w.
PubMed 34006331
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Critical Analysis of Hepatocellular Carcinoma Trials: Perspectives From Patient Experiences
- ClinicalTrials.gov ID
- NCT05859945
- Acronym / sponsor ID
- 82127001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 May 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 study, both positive and negative.
The goal is to identify the obstacles and challenges that prevent participation in hepatocellular carcinoma clinical research, as well as the reasons for withdrawal or discontinuation.
Insights gained from this study will ultimately benefit those with hepatocellular carcinoma who may be invited to participate in clinical 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
- Patients with hepatocellular carcinoma who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Diagnosed with hepatocellular carcinoma
- Willing to comply with all study related procedures and assessments
- Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Key exclusion criteria (3 listed)
- No documented diagnosis of hepatocellular carcinoma
- Any serious and/or unstable pre-existing medical disorders
- Pregnant or lactating woman
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
Rate of patients who decide to enroll in a hepatocellular carcinoma clinical study.
Time frame: 3 months
Number of hepatocellular carcinoma study participants who remain in clinical trial until 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 16 May 2023.
- Background: PubMed 22363115Frenette C, Gish R. Targeted systemic therapies for hepatocellular carcinoma: clinical perspectives, challenges and implications. World J Gastroenterol. 2012 Feb 14;18(6):498-506. doi: 10.3748/wjg.v18.i6.498.
- Background: PubMed 34126063Haber PK, Puigvehi M, Castet F, Lourdusamy V, Montal R, Tabrizian P, Buckstein M, Kim E, Villanueva A, Schwartz M, Llovet JM. Evidence-Based Management of Hepatocellular Carcinoma: Systematic Review and Meta-analysis of Randomized Controlled Trials (2002-2020). Gastroenterology. 2021 Sep;161(3):879-898. doi: 10.1053/j.gastro.2021.06.008. Epub 2021 Jun 12.
- Background: PubMed 34006331Luo XY, Wu KM, He XX. Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets. J Exp Clin Cancer Res. 2021 May 18;40(1):172. doi: 10.1186/s13046-021-01968-w.
- 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 Hepatocellular Carcinoma, 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 3 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 16 May 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?
Rate of patients who decide to enroll in a hepatocellular carcinoma 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 NCT05859945, 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 16 May 2023.