Actively Recruiting

Phase Not Applicable
Age: 50Years - 74Years
FEMALE
ID05195385

Lung Cancer Screening With Low-dose CT Scan in Women: Implementation Study

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-30

2635

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

M

Ministère de la Santé et des Solidarités

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether a single general radiologist, trained in lung cancer screening, can accurately read low-dose thoracic CT scans compared to the traditional double reading by expert radiologists. The study focuses on women aged 50 to 74 years who are at risk for lung cancer due to a significant history of smoking. It also explores the use of artificial intelligence to assist in lung nodule detection during the reading process. Participants will undergo low-dose CT scans of the chest at three time points: baseline, one year, and two years. Initially, the CT scans will be reviewed onsite by a trained general radiologist first without and then with the assistance of an AI algorithm designed to detect lung nodules. Meanwhile, two expert chest radiologists will independently read all scans, resolving any disagreements through consensus. Patient care decisions will be based on the expert double reading results. Criteria for positive findings include nodules exceeding specific size or growth thresholds. During the study, participants will be monitored through these annual CT scans for two years, with adherence to screening and smoking cessation impact also assessed. Researchers will analyze diagnostic accuracy, concordance between readers and AI, psychological effects, comorbidity detection, and cost implications. The main outcome is the performance of trained radiologists in lung cancer screening over two years, alongside evaluation of AI's added value and other secondary outcomes related to screening effectiveness and participant health.

CONDITIONS

Brief Title

Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study

Who Can Participate

Age: 50Years - 74Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged from 50 to 74 years
  • At least 20 pack years of smoking and quit less than 15 years ago
  • Given consent and agreed to a 2-year follow-up
  • Affiliated with the social security system
Not Eligible

You will not qualify if you...

  • Clinical symptoms suggesting cancer or infection (weight loss, coughing blood, fever)
  • Current or evolving cancer
  • History of lung cancer
  • Unable to commit to 2-year follow-up
  • Chest CT scan performed within 2 years before the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 2 years

Participants undergo low-dose CT scans of the chest at baseline, 1 year, and 2 years to detect suspicious lung nodules, with readings by trained radiologists and expert consensus.

3 visits (baseline, 1 year, and 2 years; in-person)

Trial Site Locations

Total: 1 location

1

Hôtel-Dieu

Paris, France, 75004

Actively Recruiting

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Research Team

M

Marie-Pierre REVEL, PhD

A

Adèle BELLINO, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Lung CAncer SCreening in French women using low-dose CT and Artificial intelligence for DEtection: the CASCADE study protocol.

Marie-Pierre Revel, Hendy Abdoul, Guillaume Chassagnon...

https://pubmed.ncbi.nlm.nih.gov/36600392