Arsenic Exposure and Lung Cancer Incidence

NCT ID: NCT04125381

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-14

Study Completion Date

2019-03-18

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Incident Cases of Lung Cancer (Code ICD-O C340-C349)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

Exposure to Arsenic by drinking water

Intervention Type OTHER

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

Exposure to Arsenic by drinking water

Intervention Type OTHER

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

Interventions

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Exposure to Arsenic by drinking water

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Palombi

Leonardo Palombi, Full Professor of Hygiene and Preventive Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonardo Palombi, MD

Role: PRINCIPAL_INVESTIGATOR

University Rome Tor Vergata, Roma (Italy)

Locations

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Cancer Registry Viterbo Province

Viterbo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ArsenicVT2019

Identifier Type: -

Identifier Source: org_study_id

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