NCT07513818

Brief Summary

The main objective is to estimate the detection rate of lung cancer in the population screened by low-dose chest CT scans.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
67mo left

Started Jun 2026

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

February 3, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

May 20, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

February 3, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

ScreeningLung cancerComputed TomographyX-RaySmoking cessation

Outcome Measures

Primary Outcomes (1)

  • Lung cancer detection rate in the population screened using low-dose chest CT

    Number of individuals with detected cancer divided by the number of individuals included in the study, i.e., an intention-to-screen analysis.

    42 months

Secondary Outcomes (23)

  • Evaluation of screening performance

    42 months

  • Exploration and comparison of several methods for identifying and inviting the target population

    18 months

  • Measurement of participation rate

    18 months

  • Measurement of response rates to follow-up invitations

    42 months

  • Measurement of adherence to screening rounds

    18 months , 30 months & 54 months

  • +18 more secondary outcomes

Interventions

Baseline low-dose CT acquisition, then at 1 year and 3 years to depict suspicious lung nodules

Eligibility Criteria

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

You may qualify if:

  • Adults aged 50-74 years
  • Active or former smoker having quit less than 15 years ago
  • Smoking history of at least 20 pack-years, or 15 cigarettes/day for 25 years or 10 cigarettes/day for 30 years
  • Affiliation with a social security scheme
  • Written informed consent prior to study participation

You may not qualify if:

  • Chest CT scan performed within the previous 12 months
  • Signs of respiratory infection (fever, productive cough)
  • Severe co-morbidities contraindicating exploration and/or management (including stereotactic surgery or radiotherapy) of lung cancers
  • Poor general status (PS2 and above)
  • Rest dyspnea (mMRC4)
  • Cancer under active surveillance by thoracic computed tomography (CT pr PET-CT)
  • Personal history of lung cancer
  • Symptoms raising suspicion of lung cancer (hemoptysis, unexplained weight loss, recent onset or modification of respiratory symptoms,…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HCL - Hôpital Lyon Sud

Lyon, France, 69495, France

Location

Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesHealth BehaviorBehavior

Study Officials

  • Marie-Pierre REVEL, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Sébastien COURAUD, PhD

    Hospices Civils de Lyon

    STUDY CHAIR

Central Study Contacts

Marie-Pierre REVEL, PhD

CONTACT

Alice CAMARA, MSc

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 3, 2026

First Posted

April 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

May 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations