Returning Genetic Results on Arsenic Susceptibility

NCT05072132 | Completed

• 1 other identifier: IRB20-1058
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• change in arsenic concentration in urine

  Urine samples will be obtained by URB study staff at baseline (Time1 or initial contact) and Time2 (Six months after the onset of the intervention). Urine arsenic will be measured using Inductively Coupled Plasma Mass spectrometry (ICPMS) at the CACHET (The Chicago Center for Health and Environment) biomarkers core facility at UIC (University of Illinois at Chicago). The difference between arms in the change in arsenic from time 1 to time 2 will be assessing using regression-based statistical methods.

  six months

Secondary Outcomes (1)

• Psychological stress

  six months

Study Arms (3)

Inefficient metabolizers

EXPERIMENTAL

Participants will be selected based on being inefficient arsenic metabolizers. A standard informational intervention will be provided, reminding them of the effects of arsenic exposure and strategies to reduce their exposure. This intervention group will additionally be provided information on their arsenic metabolism efficiency (i.e., their genetic results indicating they are inefficient metabolizers and at increased risk for arsenic toxicities).

Other: Personal information on genetic susceptibility to arsenic toxicity; Other: standard information on arsenic exposure reduction

Efficient metabolizers

EXPERIMENTAL

Participants will be selected based on being efficient arsenic metabolizers. A standard informational intervention will be provided, reminding them of the effects of arsenic exposure and strategies to reduce their exposure. This intervention group will additionally be provided information on their arsenic metabolism efficiency (i.e., their genetic results indicating they are efficient metabolizers and at decreased risk for arsenic toxicities).

Other: Personal information on genetic susceptibility to arsenic toxicity; Other: standard information on arsenic exposure reduction

Control group

ACTIVE COMPARATOR

The control group will consist of a random sample of HEALS participants. A standard informational intervention will be provided, reminding them of the effects of arsenic exposure and strategies to reduce their exposure. No information on arsenic metabolism efficiency will be provided during the study period (option to receive after the study)

Other: standard information on arsenic exposure reduction

Interventions

Personal information on genetic susceptibility to arsenic toxicity OTHER

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.

Efficient metabolizers; Inefficient metabolizers

standard information on arsenic exposure reduction OTHER

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.

Control group; Efficient metabolizers; Inefficient metabolizers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• HEALS cohort members
• age 18-70
• consistently high urine arsenic levels (≥ 200 µg/g creatinine) based on 15-20 years of follow-up data
• existing data on genetic information regarding the AS3MT variants that classify them as being an inefficient or efficient arsenic metabolizer.
• missing baseline urine samples
• missing the latest follow-up urine samples.
• There will be a total of 300 subjects enrolled,100 for the intervention 1 group, 100 for the intervention 2 group and 100 for the control group.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

UChicago Research Bangladesh

Dhaka, Dhaka-1230, Bangladesh

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 8, 2021
• Study Start: August 16, 2021
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)