NCT05704920: DACAPO

Integrating Artificial Intelligence Into Lung Cancer Screening.

Recruiting now NA Last updated 12 April 2024

What this trial tests

NA trial testing IA in Lung Cancer in 2,722 participants. Currently enrolling.

Timeline

8 April 2024

Primary endpoint
1 March 2029

1 October 2030

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	2,722
Start date	8 April 2024
Primary completion	1 March 2029
Estimated completion	1 October 2030
Sites	1 location across France

Drugs / interventions tested

• IA
• Not IA

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

Adults 18 to 80, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Integrating artificial intelligence into lung cancer screening: a randomised controlled trial protocol.
   Benzaquen J, Hofman P, Lopez S, Leroy S, et al · · 2024 · cited 4× · PMID 38355174 · DOI 10.1136/bmjopen-2023-074680