Returning Genetic Results on Arsenic Susceptibility

Summary

In recent years, returning genetic results to research participants has become a topic of debate, with a growing consensus that researchers should offer to return incidental findings and research results to participants. Currently, the research and debates surrounding return of results (ROR) have primarily taken place in high-income countries. Less attention has been paid to ROR in lower-resource countries. However, research participants in these settings may have additional threats, barriers, and/or competing interests that reduce the benefit or relevance of receiving genetic results.

Arsenic is a toxic metal. Exposure to arsenic increases a person's risk for cancer, especially in the lung, kidney, bladder and skin. Many people in Bangladesh are exposed to elevated environmental levels of arsenic through naturally contaminated drinking water. People who metabolize arsenic (remove it from their body) slower compared to people who metabolize arsenic more efficiently are at higher risk for arsenic toxicities (e.g. cancer).

The investigators have designed a study in which they plan to enroll individuals who have had consistently high urine As levels (≥200 µg/g creatinine) based on 15-20 years of follow-up data. The treatment and control groups will be selected based on genotype (i.e. inefficient and efficient As metabolizers, respectively), allowing for the selection of the groups to be quasi-random (based on inherited genotypes). A standard informational intervention will be provided to both the treatment and controls groups, reminding them of the effects of As exposure and strategies to reduce their exposure.

The research question is whether the treatment group will, have a larger decrease in urine arsenic levels compared to the control group, indicating that the ROR intervention caused a change in water-seeking behavior leading to lower arsenic exposure.

Conditions

• Arsenic Exposure

Interventions

OTHER

Personal information on genetic susceptibility to arsenic toxicity

The intervention groups will receive information regarding their genetic results that informs them of their arsenic metabolism efficiency. They will receive this information through a factsheet appropriate for a lay audience. The factsheet will contain information regarding arsenic metabolism and its role in removing arsenic from the body. The factsheet will describe how there is variability among individuals with respect to the efficiency with which arsenic is removed from the body, due to inherited differences in genes that affect arsenic metabolism. The factsheet describe how slower metabolizers remove arsenic slower from the body, which leads to increased in toxicity risk. The factsheet will inform participants in the intervention groups that they have been identified as a slow/fast metabolizer of arsenic based on their genes. This information will be given to participants by the URB staff, with a study physician available to address questions and concerns from the participant.

OTHER

standard information on arsenic exposure reduction

In this study, intervention and control groups will receive a standard informational intervention which will remind them of the effects of arsenic exposure and potential strategies that can be implemented to reduce their exposure.

Sponsors & Collaborators

• University of Chicago

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-08-16

Primary Completion

2022-12-31

Completion

2023-05-31

Countries

• Bangladesh

Study Locations