Navigating the Clinical Trial Process for Hepatocellular Carcinoma

NCT05859945 | Not Yet Recruiting

• 1 other identifier: 82127001
• 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 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

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a hepatocellular carcinoma clinical study.

  3 months

• Number of hepatocellular carcinoma study participants who remain in clinical trial until 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

Patients with hepatocellular carcinoma who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.

You may qualify if:

• 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

You may not qualify if:

• No documented diagnosis of hepatocellular carcinoma
• Any serious and/or unstable pre-existing medical disorders
• Pregnant or lactating woman

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 22363115 BACKGROUND

• Haber 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.

  PMID: 34126063 BACKGROUND

• Luo 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.

  PMID: 34006331 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver 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: May 5, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2023

Record last verified: 2023-05