NCT05195385

Brief Summary

The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts. The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,635

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 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 Progress79%
Apr 2022Oct 2027

First Submitted

Initial submission to the registry

January 4, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 8, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

January 4, 2022

Last Update Submit

March 25, 2026

Conditions

Lung Cancer Screening

Keywords

lung neoplasmsmultidetector computed tomographyearly detection of cancerartificial intelligencelung cancer screening

Outcome Measures

Primary Outcomes (1)

  • Performance of trained radiologists for lung cancer screening

    Sensitivity, specificity, predictive values compared to double reading by experts

    2 years

Secondary Outcomes (10)

  • Effectiveness of screening

    2 years

  • Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value

    2 years

  • Analysis of the performance of a reading by detection software alone

    2 years

  • Analysis of the concordances of the different readings

    2 years

  • Adherence to screening

    2 years

  • +5 more secondary outcomes

Study Arms (1)

Procedure

OTHER

Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules

Procedure: Low-dose computed tomography of the chest

Interventions

Low-dose computed tomography of the chestPROCEDURE

Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules

Procedure

Eligibility Criteria

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

You may qualify if:

  • Women aged from 50 to 74 years
  • who had smoked at least 20 pack years and quit less than 15 years ago
  • Had given their consent and accepted the need for a 2-year follow-up
  • Affiliated to the social security system

You may not qualify if:

  • Presence of clinical symptoms suggesting malignancy (weight loss, hemoptysis) or ongoing infection (cough with fever)
  • Evolving cancer
  • History of lung cancer
  • A 2-year follow-up not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôtel-Dieu

Paris, 75004, France

RECRUITING

Related Publications (1)

  • Revel MP, Abdoul H, Chassagnon G, Canniff E, Durand-Zaleski I, Wislez M. Lung CAncer SCreening in French women using low-dose CT and Artificial intelligence for DEtection: the CASCADE study protocol. BMJ Open. 2022 Dec 8;12(12):e067263. doi: 10.1136/bmjopen-2022-067263.

    PMID: 36600392DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marie-Pierre REVEL, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Marie WISLEZ, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Pierre REVEL, PhD

CONTACT

+33 1 42 34 79 10marie-pierre.revel@aphp.fr

Adèle BELLINO, MS

CONTACT

+33 1 58 41 11 95adele.bellino@aphp.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

January 4, 2022

First Posted

January 19, 2022

Study Start

April 8, 2022

Primary Completion (Estimated)

October 8, 2027

Study Completion (Estimated)

October 8, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

FR(1)