PROJECT INTERESTS

Our ACAPULCO project should allow:

Test lung cancer screening in Corsica,

Complete and enrich elements of knowledge in a French context
Raising public awareness of the harmful effects of tobacco,
Evaluate the impact of asbestos, radon, tobacco and maritime pollution (smoke plume) on people's health.

Interest for the patient:

This low-radiation chest scanner screening project is based on very recent medical and scientific knowledge and aims initially to reduce lung cancer mortality but also general mortality.

Interest for the population:

The public health benefits are:

Mobilize the main medical actors on a restricted territory,
To involve liberal doctors in a screening mission in association with the actors of the hospital centers of Bastia and Ajaccio,
Widely disseminate information contributing to the fight against tobacco use,
Compare the areas of influence of the main pollutants known to fight against lung cancer (asbestos, radon, urban area with active commercial port).

screening

In Europe, an expert opinion published in 2015 recommended that screening be carried out as part of research programs or routine care organized in accredited centers only.
More recently, the French Institute of Thoracic Surgery has clearly positioned itself on the considerable challenge represented by lung cancer screening and the relevance of this screening following the results of the NELSON study.

This study carried out on 15,792 people, divided into two groups, a “scanner” group on inclusion and a “control” group with scheduled examinations on demand. A total of 261 lung cancers were detected before the fourth round of follow-up. The use of chest CT screening in men without symptoms at high risk for lung cancer resulted in a 26% reduction in lung cancer deaths after 10 years of follow-up.

In the subgroup of women, which was smaller, the reduction was even greater, with the risk of death from lung cancer being reduced by 39% to 61% after several years of follow-up, indicating an even greater reduction. and significantly lower lung cancer mortality than in men.

These results confirm those of the American National Lung Screening Trial (NLST) study, which demonstrated in 2011 that low-radiation chest CT screening performed on more than 53,000 individuals at risk reduces lung cancer mortality by 20%. . In addition, this study showed for the first time in cancer screening, a significant reduction of 7% in general mortality (all causes combined).

Projet ACAPULCO: Intérêts

Dépistage

GOALS

The main objective is to demonstrate the feasibility of a study making it possible to know the total number of cases of lung cancer in the general population and thus demonstrate the importance of setting up organized screening in Corsica, a region with a lung cancer mortality rate higher than the national average.

The secondary objectives are:

Raise public awareness of tobacco as the main risk factor for lung cancer,
Raising public awareness of the aid available in terms of smoking cessation,
Allow the management of pathologies associated (neuro-cardio-vascular and respiratory in particular) with tobacco,
Increase the level of knowledge about lung cancer screening in the territory.

Projet ACAPULCO: Objectifs

METHOD

General scheme

The method consists of tracking down and monitoring Corsican residents who are smokers or former smokers and performing low-dose scanners for 3 years.

Information and Recruitment

Information campaigns will be carried out on the territory to inform the public. You can ask your general practitioner (or specialist) to participate in the research.

You will be asked for informed consent and you will receive an information letter, following which the general practitioner will refer you to a pulmonologist who will carry out a clinical examination and possibly suggest that you benefit from a low-radiation scanner every year for three years.

In the event of an abnormal image, you will be treated.

In the event of a normal image, you will continue the follow-up protocol for three years without upfront costs. You will also benefit from a smoking cessation program.

Are eligible to enter the study:

- Accumulating smoking for 30 packs of years, e.g. 40 cigarettes/day for 15 years (or 20 cigarettes/day for 30 years),

- Active or weaned smoker for less than 15 years,

- No apparent symptoms,

- Likely to be eligible for surgery,

- Having given consent,

- Residing in Corsica.

Are not eligible to enter the study:

Pregnant women,
People with a history of malignancy with the exception of carcinoma in situ of the cervix and basal cell carcinoma of the skin,
People with clinical signs suggestive of an evolving tumor pathology,

People with severe heart failure (NYHA Stage 4) or people who have had a myocardial infarction in the last 6 months,
People with ongoing pneumonia at the time of inclusion,
Patients with dementia or impaired intellectual faculties making questioning difficult,
People who have had significant exposure to asbestos,
People with a known history of lung disease whose x-ray images may suggest cancer,
People outside the 50-74 age group,
Persons under legal protection.

People initially included in the study will not be able to follow the 3-year follow-up in the event of:

Pregnancy,
Participation in another clinical study,
Serious intercurrent disease limiting surgical treatment.

Projet ACAPULCO: Méthode

Projet ACAPULCO: Points éthiques

ETHICAL POINTS

Training of professionals

Prior information and training for general practitioners and pulmonologists will be organized before the launch of the study. The recruitment methods, the follow-up and the expected objectives of the study will be shared by all the healthcare professionals taking part in the research.

Patient information and informed consent

Prior to the start of the research, the doctor who participates in the project is responsible for informing the person about the progress of interventional research with minimal risk and its consequences.

The patient must also be informed of any medical alternatives, of the medical care arrangements provided at the end of the research and of his right to be informed of the overall results of the research.

Informed, free and express consent will be collected in writing (article L-1122-1 of the Public Health Code) knowing that the patient will have the opportunity to ask questions and will be informed of his right to refuse to participate in the research. and withdraw at any time from the experiment without giving any justification and without prejudice to this fact.

The consent must be adapted to the understanding of the greatest number and a period of 48 hours maximum of reflection is planned between the delivery of the information and the collection of the consent.

The doctor who includes the patient will give to sign the informed consent, in duplicate; he will keep the original, give the copy to the patient.

For safety and the continuation of the study, the subject will be asked not to participate in another clinical study for the duration of the follow-up protocol, i.e. 3 years and 6 months. It is indeed recommended not to multiply radiological examinations over time.

Certain drugs tested in clinical studies may also interfere with low-dose CT images and make it difficult to interpret imaging results in the ACAPULCO study.

Data privacy

The medical and non-medical personnel participating in the trial are subject to medical and professional secrecy with respect to the data collected during the study on the patient.

The data relating to the study will be recorded by the investigators in a paper observation notebook produced by the CRCDC-Corse.

Data relating to the results of clinical and radiological examinations will be collected in a computerized and anonymous manner. The collection notebooks and associated sheets will be centralized by the investigators who will be responsible for delivering them to the CRCDC-Corse. The informed consent form will include wording that complies with relevant data protection and privacy legislation.

All documents will be kept confidentially at the firm.

Registration of the trial in the reference databases:

The trial was registered in the national database, managed by the National Agency for the Safety of Medicines and Health Products (ANSM), which lists all the biomedical research carried out by French sponsors under the ANSM number. 2020-A000174-35.

For more information, it is possible to access the complete research protocol by contacting the Direction of the CRCDC Corse 25 ter Rue Luce de Casabianca 20200 BASTIA.