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OpenTrials
Completed

NCT Number: NCT04125381

Arsenic Exposure and Lung Cancer Incidence

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Registry Viterbo Province

Viterbo, 01100, Italy

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to Arsenic by drinking water

Other

People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L), were considered as exposed.

Primary outcomes

  1. Incident cases of lung cancer

    Time frame: 2006-2012

    Incident cases of lung cancer (code ICDO C340-C349), recorded by Viterbo Cancer Registry

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.