Social Determinants of Health in Hepatobiliary Cancer Patients

February 3, 2026 updated by: Mayo Clinic
This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Nguyen H. Tran, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with hepatobiliary cancers

Description

Inclusion Criteria:

  • Patients 18+ year of age with hepatobiliary cancers

Exclusion Criteria:

  • Patients under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?".
Baseline; up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Nguyen H. Tran, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2023

Primary Completion (Estimated)

July 17, 2028

Study Completion (Estimated)

July 17, 2028

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 22-012368 (Other Identifier: Mayo Clinic in Rochester)
  • NCI-2023-05784 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • K23MD017217 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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