NCT07392775

ALDH2 Genetic Testing in East Asian Community

A Community-Based Approach for ALDH2 Genetic Testing in East Asian Americans

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn whether education plus genetic testing for ALDH2\*2 and ADH1B\*2 is feasible and acceptable and whether it influences modifiable health behaviors in East Asian American adults who experience alcohol flushing when they drink alcohol or have a family history of flushing. The main questions it aims to answer are: 1. Is providing education plus ALDH2\*2/ADH1B\*2 genetic testing feasible and acceptable in a clinical care context? 2. Does receiving genetic testing results plus education lead to changes in modifiable health behaviors compared with education alone? Researchers will compare education plus genetic testing (intervention arm) to education only (control arm) to see if adding genetic testing improves feasibility/acceptability and supports health behavior change. Participants will: 1. Complete an education module about alcohol flushing and ALDH2/ADH1B 2. Be randomized to either: (A) Receive genetic testing for ALDH2\*2 and ADH1B\*2 with results disclosure, or (B) Receive education only. 3. Complete follow-up measures about feasibility, acceptability, and modifiable health behaviors

Detailed description

Alcohol flushing syndrome affects an estimated \>500 million individuals worldwide and is strongly associated with functional variants in alcohol metabolism genes, particularly ALDH2 (e.g., ALDH2\*2) and ADH1B (e.g., ADH1B\*2). ALDH2\*2 reduces aldehyde dehydrogenase activity, contributing to acetaldehyde accumulation and is associated with increased risk for alcohol-related morbidity, including certain cancers and cardiometabolic outcomes. Despite the public health relevance, ALDH2/ADH1B implementation in clinical care remains limited, and evidence-based strategies are needed to support equitable and ethical adoption, especially for populations underrepresented in genomics research. This study will engage the East Asian American community to evaluate implementation strategies for ALDH2\*2 and ADH1B\*2 genetic testing and education in clinical settings and to examine the behavioral impact of returning genetic risk information. Using a pragmatic, randomized comparative effectiveness pilot design, East Asian American adults who self-report alcohol flushing and/or a family history of flushing will be randomized to either: (1) education plus ALDH2\*2/ADH1B\*2 genetic testing with genotype-informed result disclosure, or (2) education alone. Primary outcomes are feasibility and acceptability of the testing-and-education approach; secondary outcomes include changes in modifiable health behaviors (e.g., alcohol-related decision-making) following education with or without genetic result return. Findings will inform scalable implementation pathways and contribute to equitable integration of genomic testing into routine care for populations experiencing healthcare disparities.

Conditions

• Healthy Adult
• Flushing

Interventions

Type	Name	Description
BEHAVIORAL	Genetic Test Results Return	Returning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B)
BEHAVIORAL	Alcohol Flushing Education	Administering alcohol flushing educational module.

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-06-01
• Completion: 2029-06-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States