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NCT06053333 Clinical Trial

Social Determinants of Health in Hepatobiliary Cancer Patients

Malignant Hepatobiliary Neoplasm Clinical Trial

Official title:
Social Determinants of Health in Hepatobiliary Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06053333
Other study ID # 22-012368
Secondary ID NCI-2023-0578422
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2023
Est. completion date July 17, 2028

Study information
Verified date September 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer.

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 Southeast Asian 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 sample collection and have their medical records reviewed on study.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date July 17, 2028
Est. primary completion date July 17, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients 18+ year of age with hepatobiliary cancers Exclusion Criteria: - Patients under 18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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?". Baseline; up to 2 years
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Recruiting NCT04704661 - Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Patients With Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial Phase 1
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