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NCT Number: NCT05704920

Integrating Artificial Intelligence Into Lung Cancer Screening.

Lung cancer (LC) screening using low-dose chest CT (LDCT) has already proven its efficacy.

The mortality reduction associated with LC screening is around 20%, much higher than the reduction in mortality associated with screening for breast, colon or prostate cancers.

Implementing lung cancer screening on a large scale faces two main obstacles:

1. The lack of thoracic radiologists and LDCT necessary for the eligible population (between 1.6 and 2.2 million people in France); 2. The high frequency of false positive screenings: in the NLST trial, more than 20% of the subjects screened were found to have at least one nodule of an indeterminate lung nodule (ILN) whereas less than 3% of ILNs are actually LC.

The gold standard for determining on the benign or malignant nature of a nodule is definitive histology. Otherwise, the evolution of the nodule on serial thoracic imaging is a good alternative. The period of indeterminacy of a nodule can be as long as 24 months in many cases, which can be a source of prolonged and sometimes unjustified anxiety for screening candidates.

The purpose of this randomized controlled study that focuses on LC screening in patients aged 50 to 80 years, who smoked more than 20 packs/ year or stopped smoking less than 15 years ago. Its objective is to determine whether assisting multidisciplinary team (MDT) meetings with an AI-based analysis of screening LDCT accelerates the definitive classification of nodules into malignant or benign.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 50 and 80 years old
  • active smoker or ex-smoker who quit smoking less than 15 years ago
  • smoking history of at least 20 pack-years
  • signature of the informed consent
  • affiliation to French social security

Exclusion criteria

  • clinical signs suggestive of cancer
  • recent chest scan (<1 year) for another cause
  • radiological abnormality requiring follow-up or additional investigations
  • health problem significantly limiting life expectancy from the clinician's point of view
  • health problem limiting ability or willingness to undergo lung surgery
  • Patients with active neoplasia, except basal cell carcinoma of the skin.
  • vulnerable people: adults under guardianship, adults under curatorship medical and/or psychiatric problems of sufficient severity to limit full adherence to the study or expose patients to excessive risk

Treatment and study plan

IA

Other

The multidisciplinary team meeting discussion is informed of the AI-based analysis of their chest computed tomography

Not IA

Other

The multidisciplinary team meeting discussion is not informed of the AI-based analysis of their chest computed tomography

Primary outcomes

  1. Diagnosis of lung disease

    Time frame: At 3 years

    Elapsed time between lung nodule discovery and MDT decision making.

Secondary outcomes

  1. Operating characteristics of Ai-based strategy

    Time frame: At 3 years

Study contacts

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

Boutros Jacques

CONTACT

[email protected]

+33492037777

Marquette Charles-Hugo, PhD

CONTACT

[email protected]

+33492037777

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

A Randomized Controlled Study of Including a Deep Learning-based Analysis of Chest Computed Tomography as an Aid to Decision Making of Multidisciplinary Team Meetings for Lung Cancer Screening in Eligible Patients

Acronym: DACAPO

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Jan 30, 2023
Registry last updated
Apr 12, 2024

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.

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