Arsenic Exposure and Lung Cancer Incidence

Sponsor
University of Rome Tor Vergata (Other)
Overall Status
Completed
CT.gov ID
NCT04125381
Collaborator
(none)
314,000
1
2.1
151704.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure to Arsenic by drinking water

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
314000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Chronic Exposure to Arsenic and Risk of Lung Cancer Among Residents in the Province of Viterbo, Central Italy.
Actual Study Start Date :
Jan 14, 2019
Actual Primary Completion Date :
Mar 18, 2019
Actual Study Completion Date :
Mar 18, 2019

Arms and Interventions

Arm 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

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.

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

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.

Outcome Measures

Primary Outcome Measures

  1. Incident cases of lung cancer [2006-2012]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Registry Viterbo Province Viterbo Italy 01100

Sponsors and Collaborators

  • University of Rome Tor Vergata

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leonardo Palombi, Leonardo Palombi, Full Professor of Hygiene and Preventive Medicine, University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT04125381
Other Study ID Numbers:
  • ArsenicVT2019
First Posted:
Oct 14, 2019
Last Update Posted:
Oct 29, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2019