Malignant Hepatobiliary NeoplasmNCT06053333
Social Determinants of Health in Hepatobiliary Cancer Patients
An observational study of Malignant Hepatobiliary Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hepatobiliary Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 17 Jul 2028
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with hepatobiliary cancers
Who may be able to join
- Patients 18+ year of age with hepatobiliary cancers
Who cannot join
- Patients under 18 years of age
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Nguyen H. Tran, M.D.
About this study
This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To characterize the social determinants of health - and specifically travel-limiting access to cancer care but also other issues, such as trouble in finding childcare, joblessness, and limited education - among SEA Americans with hepatobiliary cancers, exposure risk including aflatoxin and viral hepatitis among other exposures.
OUTLINE: This is an observational study.
Patients complete a questionnaire, undergo blood, urine, and buccal swab sample collection and have their medical records reviewed on study. Patients also undergo collection of clinically archived tissue samples on study.
- Conditions
- Malignant Hepatobiliary Neoplasm
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients complete a questionnaire, undergo blood, urine, and buccal swab sample collection and have their medical records reviewed on study. Patients also undergo collection of clinically archived tissue samples on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients reporting transportation barriers that affect medical care
Estimated using Social Determinants of Health Screening Tool designed by the American Academy of Family Medicine, by the proportion of patients who respond "yes" to the question, "Do you put off or neglect going to the doctor because of distance or transportation?".
Measured: Baseline; up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start17 Jul 2023
- Primary completion17 Jul 2028 (estimated)
- Study completion17 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Hepatobiliary NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Nguyen H. Tran, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053333
- Sponsor's protocol ID
- 22-012368
- Other IDs
- NCI-2023-05784, 22-012368, K23MD017217
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Determinants of Health in Hepatobiliary Cancer Patients
- ClinicalTrials.gov ID
- NCT06053333
- Acronym / sponsor ID
- 22-012368
- Conditions
- Malignant Hepatobiliary Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 17 Jul 2028 (estimated)
- Study completion
- 17 Jul 2028 (estimated)
- First posted
- 25 Sep 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.
This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer.
Detailed description
PRIMARY OBJECTIVE:
- To characterize the social determinants of health - and specifically travel-limiting access to cancer care but also other issues, such as trouble in finding childcare, joblessness, and limited education - among SEA Americans with hepatobiliary cancers, exposure risk including aflatoxin and viral hepatitis among other exposures.
OUTLINE: This is an observational study.
Patients complete a questionnaire, undergo blood, urine, and buccal swab sample collection and have their medical records reviewed on study. Patients also undergo collection of clinically archived tissue samples on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients complete a questionnaire, undergo blood, urine, and buccal swab sample collection and have their medical records reviewed on study. Patients also undergo collection of clinically archived tissue samples on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with hepatobiliary cancers
Key inclusion criteria (1 listed)
- Patients 18+ year of age with hepatobiliary cancers
Key exclusion criteria (1 listed)
- Patients under 18 years of age
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Percentage of patients reporting transportation barriers that affect medical care
Time frame: Baseline; up to 2 years
Estimated using Social Determinants of Health Screening Tool designed by the American Academy of Family Medicine, by the proportion of patients who respond "yes" to the question, "Do you put off or neglect going to the doctor because of distance or transportation?".
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 4 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Nguyen H. Tran, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Hepatobiliary Neoplasm, run by Mayo Clinic 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 1 inclusion and 1 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 4 Feb 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients reporting transportation barriers that affect medical care (time frame: Baseline; up to 2 years). 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 4 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.