NCT06020443

Brief Summary

The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

August 28, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

August 28, 2023

Last Update Submit

May 13, 2025

Conditions

Keywords

screeninglow dose chest computed tomographylung cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of included patients having undergone the first screening scan

    T0

Secondary Outcomes (7)

  • Rate of patients who refused to participate in the screening program

    1 year

  • Rate of included patients having completed CT scans at each stage of follow-up

    3 years

  • Number of patients newly committed to smoking cessation during the screening period

    3 years

  • Tobacco consumption

    3 years

  • Radiation doses received at each CT scan

    3 years

  • +2 more secondary outcomes

Study Arms (1)

Patients with a high risk of lung cancer

OTHER
Procedure: Low Dose chest CT Scan for Lung Cancer Screening

Interventions

Low dose CT scans will be performed for three years

Patients with a high risk of lung cancer

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 50 to 74 years
  • Smoking OR having smoked (withdrawal of \<15 years): ≥15 cigarettes/day for ≥25 years OR ≥10 cigarettes/day for ≥30 years
  • Affiliated or beneficiary of a social security scheme
  • Written informed consent

You may not qualify if:

  • Inability to walk up two flights of stairs without stopping
  • BMI \> 35 kg/m²
  • Recent chest CT scan \< 1 year
  • Personal history of lung cancer \< 5 years or under treatment
  • Personal history of cancer being monitored by chest CT scan
  • Contraindication to lung cancer treatment or diagnostic investigations
  • Current or recent respiratory symptoms immediately suggestive of lung cancer
  • Pregnant or breast-feeding woman
  • Person under court protection, guardianship or curatorship
  • Person deprived of liberty by judicial or administrative decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabinet de médecine générale

Colmar, Haut-Rhin, 68000, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Patrick Strentz, MD

    General Practioner, Colmar, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Low Dose chest CT Scan for Lung Cancer Screening
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

August 31, 2023

Study Start

November 6, 2023

Primary Completion

November 5, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations