Involvement of General Practitioners in Lung Cancer Screening (GEDEPIST)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris
The main objective is to evaluate the adherence of smoking patients to lung cancer screening by low-dose CT scan, when proposed by the general practitioner.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung cancer is the leading cause of cancer mortality in France and worldwide. The KBP2020 study conducted in general hospitals, including 8999 patients diagnosed with lung cancer in the year 2020, showed that 73% of lung cancer cases were diagnosed at an advanced symptomatic stage, explaining the high rate of metastatic status at diagnosis, reaching 58%. For this category of patients, 3-month mortality remains very high, close to 25%. Several large randomized studies have demonstrated that lung cancer screening with low-dose CT scans enables lung cancer to be diagnosed at an early, asymptomatic stage, when it is mostly accessible to curative surgical treatment. This early detection and subsequent treatment reduced specific mortality by 20% in the NLST study, and by up to 39% at 10 years in the MILD study. Overall mortality was reduced by 6.7% in the NLST study. This scientific evidence has led the French National Authority for Health to encourage the implementation of a pilot program, to be organized by the French National Cancer Institute.

The hypothesis of the study is that the proposal of CT screening for lung cancer will be better adhered to if it is made by the general practitioner of individuals at risk. Adherence is defined by an initial scan, followed by a second scan one year after the first, with participation in screening on an annual basis.

Given the trust that generally characterizes the relationship between patients and their GP, and the fact that intercurrent consultations provide reminders of the need for an annual check-up, the assumption is for an initial participation rate of at least 50%, and a continued participation rate of 70% at 1 year.

Communication of results by the GP will help to limit anxiety, particularly in the event of an undetermined result, which will be assessed by the anxiety section of the Hospital Anxiety and Depression scale questionnaire translated into French.

In addition, the success of smoking cessation will be compared with literature data in the context of screening. The hypothesis is that the cessation rate will be higher due to the possibility of adapting nicotine substitution by the GP and his or her repeated support in the cessation process.

Finally, knowledge of patients' histories will help to limit unnecessary explorations and to better identify for which participants screening reveals COPD (emphysema), osteoporosis or unrecognized coronary artery disease.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria :

  • Adults aged 50-74
  • Active smoker or weaned smoker for less than 15 years, of at least 20 pack-years
  • Affiliation with a social security scheme or CMU (beneficiary or beneficiary entitled)
  • Written informed consent prior to study participation

Exclusion Criteria :

  • History of lung cancer
  • Thoracic CT scan performed within the previous year
  • 1-year follow-up not possible
  • Inability to travel independently to Hôpital Cochin or Hôpital Bichat for scans
  • People with severe co-morbidities contraindicating exploration and/or management of lung cancers
  • People in poor general health (=PS2 and above)
  • People with a history of cancer under active surveillance by thoracic computed tomography (CT and PET scans)
  • People with rest dyspnea (=mMRC4)
  • Recent weight loss, altered general condition or hemoptysis, raising suspicion of progressive lung cancer
  • Signs of respiratory infection (fever, productive cough)
  • Patients under guardianship, curatorship or protected adults
  • Inability to give free written informed consent prior to study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of completion of screening scan
Time Frame: 12 months
Rate of completion of screening scan, one year after initial scan.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of tobacco consumption
Time Frame: 12 months
Comparison of tobacco consumption at 1 year versus consumption at baseline
12 months
Chronic obstructive pulmonary disease (COPD)
Time Frame: Up to 12 months
Number of participants with initially unrecognized COPD confirmed by lung function tests.
Up to 12 months
Statin/aspirin prevention
Time Frame: Up to 12 months.
Number of participants for whom statin/aspirin prevention is initiated following initial scan.
Up to 12 months.
Osteoporosis
Time Frame: Up to 12 months.
Number of participants with osteoporosis not known at inclusion confirmed by bone densitometry.
Up to 12 months.
Other pathologies
Time Frame: Up to 18 months
Number of other pathologies confirmed by their reference examination.
Up to 18 months
Cancer screened
Time Frame: Up to 18 months
Rate of stage I cancers among screened cancers.
Up to 18 months
Evolution of anxiety
Time Frame: 12 months

Hospital Anxiety and Depression Scale score (anxiety section) completed by the participant at the initial scan, at 1 year (and any additional scans), at follow-up consultations with the GP (and any additional scans) and at the end of the study.

The minimum score is 0 and the maximum is 21. Higher score means worse outcome.
12 months
Characteristics of eligible population refusing screening : age
Time Frame: Day 0
Age of eligible people refusing screening
Day 0
Characteristics of eligible population refusing screening : sex
Time Frame: Day 0
Sex of eligible people refusing screening
Day 0
Characteristics of eligible population refusing screening : smoking status
Time Frame: Day 0
Smoking status of eligible people refusing screening
Day 0
Characteristics of eligible population refusing screening : level of education
Time Frame: Day 0
Level of education of eligible people refusing screening
Day 0
Characteristics of eligible population refusing screening : reason for refusal
Time Frame: Day 0
Reason for refusal of eligible people refusing screening
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Study Director: Marie-Pierre REVEL, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Céline BUFFEL du VAURE, PhD, Assistance Publique - Hôpitaux de Paris
  • Study Director: Christian GHASAROSSIAN, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230811
  • 2024-A00669-38 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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