Arsenic Exposure and Lung Cancer Incidence | NCT04125381

Studies
Arsenic Exposure and Lung Cancer Incidence

NCT04125381

Sponsor

University of Rome Tor Vergata

Status

Completed

Last Update Posted

Oct 29, 2019Actual

Enrollment

314,000Actual

Phase

Not provided

Conditions

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

Interventions

Exposure to Arsenic by drinking water

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2019Actual

Primary Completion Date

Mar 18, 2019Actual

Completion Date

Mar 18, 2019Actual

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2019

Last Update Posted Date

Oct 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leonardo Palombi, Leonardo Palombi, Full Professor of Hygiene and Preventive Medicine, University of Rome Tor VergataPrincipal Investigator

Lead Sponsor

University of Rome Tor VergataOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

314,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incident cases of lung cancer	Incident cases of lung cancer (code ICDO C340-C349), recorded by Viterbo Cancer Registry	2006-2012

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All the residents of the Viterbo Province, Central Italy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonardo Palombi, MD	University Rome Tor Vergata, Roma (Italy)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Registry Viterbo Province		Viterbo		01100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided