- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125381
Arsenic Exposure and Lung Cancer Incidence
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Viterbo, Italy, 01100
- Cancer Registry Viterbo Province
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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
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People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L), were considered as exposed.
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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
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People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L), were considered as exposed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incident cases of lung cancer
Time Frame: 2006-2012
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Incident cases of lung cancer (code ICDO C340-C349), recorded by Viterbo Cancer Registry
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2006-2012
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leonardo Palombi, MD, University Rome Tor Vergata, Roma (Italy)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ArsenicVT2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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