Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06956040

Involvement of General Practitioners in Lung Cancer Screening

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin

Paris, 75014, France

Location status: Recruiting

Location contact

Céline BUFFET du VAURE, PhD

CONTACT

[email protected]

Marie-Pierre REVEL, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose computed tomography of the chest

Procedure

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

Primary outcomes

  1. Rate of completion of screening scan

    Time frame: 12 months

    Rate of completion of screening scan, one year after initial scan.

Secondary outcomes

  1. Evolution of tobacco consumption

    Time frame: 12 months

    Comparison of tobacco consumption at 1 year versus consumption at baseline

  2. 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.

  3. Chronic obstructive pulmonary disease (COPD)

    Time frame: Up to 12 months

    Number of participants with initially unrecognized COPD confirmed by lung function tests.

  4. Statin/aspirin prevention

    Time frame: Up to 12 months.

    Number of participants for whom statin/aspirin prevention is initiated following initial scan.

  5. Osteoporosis

    Time frame: Up to 12 months.

    Number of participants with osteoporosis not known at inclusion confirmed by bone densitometry.

  6. Other pathologies

    Time frame: Up to 18 months

    Number of other pathologies confirmed by their reference examination.

  7. Cancer screened

    Time frame: Up to 18 months

    Rate of stage I cancers among screened cancers.

  8. Characteristics of eligible population refusing screening : age

    Time frame: Day 0

    Age of eligible people refusing screening

  9. Characteristics of eligible population refusing screening : sex

    Time frame: Day 0

    Sex of eligible people refusing screening

  10. Characteristics of eligible population refusing screening : smoking status

    Time frame: Day 0

    Smoking status of eligible people refusing screening

  11. Characteristics of eligible population refusing screening : level of education

    Time frame: Day 0

    Level of education of eligible people refusing screening

  12. Characteristics of eligible population refusing screening : reason for refusal

    Time frame: Day 0

    Reason for refusal of eligible people refusing screening

Study contacts

Contact information is provided by the study sponsor or research team.

Alice CAMARA, MSc

CONTACT

[email protected]

01 58 41 12 11 ext. +33

Céline BUFFEL du VAURE, PhD

CONTACT

[email protected]

06 61 90 03 71 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: GEDEPIST

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 2, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.