NCT04366661

Brief Summary

Lung cancer is a global problem. Worldwide, 1.2 million people die of lung cancer each year. In Iraq, lung cancer is the most common malignancy after breast cancer and the leading cause of cancer-related death. Tobacco smoking plays a major role in lung cancer; it is reported in 85-90% of lung cancer patients yet environmental tobacco smoke, environmental and domestic air pollution, work-related risk factors, radon exposure, and viruses may also have an impact on lung cancer incidence rates. Early detection of the disease before patients develop symptoms considers the best way to improve patient outcomes. IT LUCAS is designed to evaluate the utility of low-dose computed tomography (LDCT) screening in early detection and management of lung cancer in high-risk people.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

3.5 years

First QC Date

April 22, 2020

Last Update Submit

March 4, 2021

Conditions

Keywords

smokingenvirumental polution

Outcome Measures

Primary Outcomes (1)

  • The efficacy of LD CT in lung cancer screening

    The number of lung nodules with Lung RADS 4A, 4B and 4X, cancer predictive value and false-positive value

    2 years

Secondary Outcomes (1)

  • noncancerous lung lesions

    2 years

Study Arms (1)

screening

EXPERIMENTAL

Participants undergo low dose CT of the chest

Diagnostic Test: low dose CT

Interventions

low dose CTDIAGNOSTIC_TEST

Invited participants from institutes exposed to a high level of smoke pollution such as employees of Transport and Oil Ministries are inquired for their personal history of cigarette smoking then subjected to low dose CT

screening

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • aged between 50 and 75
  • smokers or ex-smoker
  • tobacco exposure of more than 30 pack-years

You may not qualify if:

  • History of cancer within the last 5 years other than non-melanoma skin cancer or carcinoma in situ,
  • heart or respiratory severe co-morbidity with contraindications to thoracoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Teaching Hospital

Baghdad, Iraq

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsSmoking

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Enam A Khalil

    Oncology Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 29, 2020

Study Start

June 1, 2018

Primary Completion

December 1, 2021

Study Completion

April 1, 2022

Last Updated

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations