Arsenic Exposure and Lung Cancer Incidence

October 25, 2019 updated by: Leonardo Palombi, University of Rome Tor Vergata

Chronic Exposure to Arsenic and Risk of Lung Cancer Among Residents in the Province of Viterbo, Central Italy.

Aim of the study was to assess any associations between chronic exposure by drinking water to Arsenic and onset of lung cancer, using a retrospective cohort study design.

Incident cases of lung cancer from 1st January 2006 to 31st December 2012, recorded by Viterbo Cancer Registry, occurring during the period, were considered as primary outcome. People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L) were considered as exposed.

Study Overview

Detailed Description

Arsenic and its compounds were classified as human carcinogens by IARC, because of their role in the onset and the progression of several neoplasms: liver, lung, bladder, prostate and skin cancer. If many studies shed to light on the existence of a strong association between As and cancer at chronic exposure to high metalloid concentrations (>150 µg/L), much remains to be clarified on the effects of low-moderate exposure, such as those occurring in Italy. The aim of this retrospective cohort study is to focus on the role of Arsenic in the pathogenesis of lung cancer, as one of the most impacting neoplasms in terms of incidence and prevalence (40.000 new diagnoses in Italy in 2017), in Viterbo Province, central Italy.

Because of its high toxicity and its ubiquitous distribution, that earned the metalloid the first in the Priority list by ATSDR, thus being a main issue in Public Health.

Materials and Methods From 1st January 2006 to 31st December 2012 all the inhabitants, residing in one of the 60 municipalities of Viterbo Province (around 320,279 people) were enrolled. Incident cases of lung cancer, recorded by Viterbo Cancer Registry, occurring during the period, were considered as primary outcome. People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L), as provided by Arpa Lazio, were considered as exposed.

Risk difference in developing lung cancer among exposed and not exposed was estimated by Relative Risk (RR) and Attributable Risk (AR).

Study Type

Observational

Enrollment (Actual)

314000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Viterbo, Italy, 01100
        • Cancer Registry Viterbo Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the residents of the Viterbo Province, Central Italy

Description

Inclusion Criteria:

From 1st January 2006 to 31st December 2012 all the inhabitants, residing in one of the 60 municipalities of Viterbo Province were enrolled.

Exclusion Criteria:

No exclusion criteria were applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed to high Arsenic concentration
All the inhabitants, residing in one of the municipalities of Viterbo Province with high Arsenic concentration in drinking water, were enrolled
People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L), were considered as exposed.
Exposed to low Arsenic concentration
All the inhabitants, residing in one of the municipalities of Viterbo Province with low Arsenic concentration in drinking water, were enrolled
People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L), were considered as exposed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident cases of lung cancer
Time Frame: 2006-2012
Incident cases of lung cancer (code ICDO C340-C349), recorded by Viterbo Cancer Registry
2006-2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Leonardo Palombi, MD, University Rome Tor Vergata, Roma (Italy)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

March 18, 2019

Study Completion (Actual)

March 18, 2019

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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