NCT06293833

Brief Summary

The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.

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
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

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

First Submitted

Initial submission to the registry

February 19, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 5, 2024

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

February 19, 2024

Last Update Submit

February 27, 2024

Conditions

Lung Cancer, Nonsmall CellLung CancerSmoking CessationLung Cancer, Small Cell

Keywords

Lung Cancer ScreeningLung CancerSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA

    Enrollment rate of eligible responders attending at least one LDCT procedure - Measured by descriptive statistics (discrete data)

    2 years

Secondary Outcomes (5)

  • Responders

    2 years

  • Number of true and false positive nodules

    2 years

  • Impact of smoking cessation intervention

    2 years

  • Success of smoking cessation intervention

    2 years

  • Evaluation of shared decision making tool

    2 years

Study Arms (1)

High-risk (ex-) smokers

EXPERIMENTAL

Prevention and early detection of lung cancer are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.

Radiation: Low-dose CT scanBehavioral: Smoking Cessation

Interventions

Low-dose CT scanRADIATION

Participants get an annual low-dose CT scan in UZA

High-risk (ex-) smokers
Smoking CessationBEHAVIORAL

Smoking cessation campagnes

High-risk (ex-) smokers

Eligibility Criteria

Age55 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The target population consists of all adult inhabitants from the following municipalities of the ELZ ZORA: Mortsel (2640), Edegem (2650), Boechout (2530), Kontich (2550), Lint (2547), Hove (2540), and having a (TBA) % risk of developing an incidental lung cancer in the following 6 years (calculated a by risk prediction model)
  • Males and females
  • years old
  • Fitness for any kind of curative therapy for lung cancer
  • Absence of prior (lung) cancer in the 5 preceding years (excluding skin basal cell carcinoma and early stage cervical cancer)
  • Having a GP or related trusted health care provider

You may not qualify if:

  • participant may not have any symptoms (cough, pain when breathing in...)
  • Body weight \>140 kg in view of the maximum charge of the CT-scan table
  • The (rare) hereditary Li-Fraumeni syndrome which gives the carriers an excess risk of X-ray induced oncogenesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZA

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsSmoking CessationSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesHealth BehaviorBehavior

Study Officials

  • Annemiek Snoeckx, MD, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 5, 2024

Study Start

September 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

March 5, 2024

Record last verified: 2023-09

Locations

BE(1)