Arsenic Exposure and Lung Cancer Incidence

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125381
• Other study ID #: ArsenicVT2019
• Status: Completed
• Start date: January 14, 2019
• Est. completion date: March 18, 2019

Study information

• Verified date: October 2019
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314000
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Cancer Registry Viterbo Province	Viterbo

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident cases of lung cancer	Incident cases of lung cancer (code ICDO C340-C349), recorded by Viterbo Cancer Registry	2006-2012