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Arsenic Exposure clinical trials

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NCT ID: NCT05072132 Active, not recruiting - Arsenic Exposure Clinical Trials

Returning Genetic Results on Arsenic Susceptibility

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

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.