Hepatocellular CarcinomaNCT06260943
Targeted Navigation in Hepatocellular Carcinoma (HCC)
A study testing Target Navigation Pilot Program in people with Hepatocellular Carcinoma and Cholangiocarcinoma, run by University of Miami at 1 site in United States.
Trial summary
The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma, Hepatobiliary Cancer
- What is being tested?
- Target Navigation Pilot Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HCC Patients:
- Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma.
- Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.0.
- Adults, age 18 or older
- Able to provide informed consent
- All other interviewees:
Show all 9Show fewer
- Advocates who will self-identify as having had HCC.
- Others who self-identify as either a caregiver or support person of an HCC patient.
- Physicians/Licensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients.
Who cannot join
- Unable to speak Spanish or English
- West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment.
- Adults unable or unwilling to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Gloria Figueroa, (305) 243-0779, gef44@med.miami.edu
Patricia Jones, MD, (305) 243-0779, pdjones@med.miami.edu
About this study
Official title: Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation
The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.
- Being tested
- Target Navigation Pilot Program
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target Navigation Pilot ProgramBehavioural
Participants will meet with a navigator, in either English, Spanish or Creole, biweekly, in person or virtually, until the first treatment appointment and every three months after. Each session will last approximately one hour; depending on the needs identified, patients will be connected to appropriate institutional or community-based resources.
| Study group | Role | What they receive |
|---|---|---|
| Aim 3: Targeted Navigation Pilot Program | Experimental | Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months. Receives: Behavioral: Target Navigation Pilot Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hours for Each Contact
The length of time of each contact will be assessed in number of hours. Contact is defined as the length of time the navigator meets with the participant.
Measured: Up to 12 months
Number of Days to First Contact
The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days.
Measured: Up to 12 months
Number of Days to First Treatment
The time to first treatment will be assessed in number of days.
Measured: Up to 12 months
Number of Months of Total Navigation
The length of total navigation will be assessed in number of months.
Measured: Up to 12 months
Number of Participants that Die Within One Year
Number of participants that die within one year of enrollment in the navigation program.
Measured: Up to 1 year
Proportion of Participants Enrolled in Clinical Research
The proportion of participants enrolled in clinical research will be reported.
Measured: Up to 12 months
Acceptability
Percentage of approached individuals who agree to participate
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Apr 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The V Foundation
- Responsible party
- Principal investigator, Patricia Jones, MD, University of Miami
- Investigators
- Patricia Jones, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260943
- Sponsor's protocol ID
- 20221220
- Other IDs
- NCI-2024-00566
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation
- ClinicalTrials.gov ID
- NCT06260943
- Acronym / sponsor ID
- 20221220
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The V Foundation
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Feb 2024 (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.
The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aim 3: Targeted Navigation Pilot Program | Experimental | Behavioral: Target Navigation Pilot ProgramParticipants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HCC Patients:
- All other interviewees:
- Physicians/Licensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients.
Key exclusion criteria (6 listed)
- Unable to speak Spanish or English
- West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment.
- Adults unable or unwilling to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target Navigation Pilot ProgramParticipants will meet with a navigator, in either English, Spanish or Creole, biweekly, in person or virtually, until the first treatment appointment and every three months after. Each session will last approximately one hour; depending on the needs identified, patients will be connected to appropriate institutional or community-based resources. | Behavioural | Aim 3: Targeted Navigation Pilot Program |
Primary outcome
Number of Hours for Each Contact
Time frame: Up to 12 months
The length of time of each contact will be assessed in number of hours. Contact is defined as the length of time the navigator meets with the participant.
Number of Days to First Contact
Time frame: Up to 12 months
The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days.
Number of Days to First Treatment
Time frame: Up to 12 months
The time to first treatment will be assessed in number of days.
Number of Months of Total Navigation
Time frame: Up to 12 months
The length of total navigation will be assessed in number of months.
Number of Participants that Die Within One Year
Time frame: Up to 1 year
Number of participants that die within one year of enrollment in the navigation program.
Proportion of Participants Enrolled in Clinical Research
Time frame: Up to 12 months
The proportion of participants enrolled in clinical research will be reported.
Acceptability
Time frame: Enrollment
Percentage of approached individuals who agree to participate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Patricia Jones, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target Navigation Pilot Program in people with Hepatocellular Carcinoma and Cholangiocarcinoma, run by University of Miami at 1 site in United States.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gloria Figueroa ((305) 243-0779, gef44@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hours for Each Contact (time frame: Up to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.