NCT05486455

Brief Summary

Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress59%
Nov 2022Oct 2028

First Submitted

Initial submission to the registry

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

5.9 years

First QC Date

August 1, 2022

Last Update Submit

December 2, 2022

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • Positive Predictive Value (PPV)

    5 years

Secondary Outcomes (11)

  • Sensitivity

    5 years

  • Specificity

    5 years

  • Early stage lung cancer detection rate (stage I and II)

    5 years

  • 5-year survival rate of patients who have undergone thoracic surgery

    5 years

  • Rate of smoking-related co-morbidities detected on low-dose CT scan

    5 years

  • +6 more secondary outcomes

Study Arms (1)

CT scan

EXPERIMENTAL
Diagnostic Test: Low-dose chest CT scan

Interventions

Low-dose chest CT scanDIAGNOSTIC_TEST

baseline, 1-year, 3-year and 5-year low-dose CT scan

CT scan

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 50-80 years old
  • Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)

You may not qualify if:

  • Recent history of chest CT scan (within 12 months)
  • Person unable to climb 2 floors
  • Weight \> 140kg
  • Personal history of cancer \< 5 years (currently being monitored by thoracic imaging)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Joseph

Marseille, France

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Arnaud Boyer, MD

    Hopital Saint Joseph Marseille

    PRINCIPAL INVESTIGATOR

  • Illies Bouabdallah, MD

    Hopital Saint Joseph Marseille

    STUDY DIRECTOR

Central Study Contacts

Cecile Bielmann

CONTACT

0033488731070cbielman@hopital-saint-joseph.fr

Study Design

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

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

November 4, 2022

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations

FR(1)