A Study to Screen for Lung Cancer in High-risk Individuals Who Have Never Smoked Using Low-dose Computed Tomography (LDCT). (NEMO)
LungScreen-NEMO: Prospective National Lung Cancer Screening Study in High-risk Never-smokers
A prospective, multicenter, national, observational study involving primary data collection to evaluate the lung cancer detection rate in high-risk never-smokers undergoing LDCT screening, with an exploratory evaluation of an artificial intelligence tool applied to imaging and blood collection for future ctDNA analysis
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 1 877-240-9479
- E-mail: information.center@astrazeneca.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population will consist of never-smokers who have at least one prespecified high-risk factor for lung cancer, recruited from approximately 10 Brazilian centers.
La description
Inclusion Criteria:
- - Sign and date the informed consent form before any study-specific procedure.
- - Be a never-smoker, defined as an individual who has smoked fewer than 100 cigarettes in their lifetime and who has no history of regular use of cigars, pipes, straw cigarettes, or hookahs.
- - Men aged 50 to 74 or women aged 40 to 74 at the time of enrollment.
- - Meet at least one of the following high-risk criteria: A first-degree relative or two second-degree relatives diagnosed with lung cancer; Current or previous occupational exposure to asbestos, nickel, arsenic, beryllium, silica, or chromium for at least 1 year; Exposure for more than five years to household smoke from coal or firewood, foundry smoke, or comparable industrial smoke; Known germline mutation in genes associated with an increased risk of lung cancer, including TP53, BRCA1, BRCA2, or ATM.
- - Be physically and medically capable of undergoing a chest CT scan in the supine position.
- - Be available for follow-up according to the study schedule.
Exclusion Criteria:
- - Previous diagnosis of invasive cancer, except for in situ neoplasms or treated non-melanoma skin tumors, when deemed clinically irrelevant by the investigator.
- - History of using cigars, pipes, straw cigarettes, or hookahs on more than 100 occasions throughout their lifetime, or regular use (≥ 1 time per week for ≥ 6 consecutive months).
- - Physical inability to remain in the supine position during a chest CT scan.
- - Inability to understand, sign, or maintain informed consent.
- - A clinical condition that, in the investigator's judgment, precludes the safe performance of study procedures or the planned follow-up.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
High-risk never-smokers
Never-smoking men aged 50 to 74 and never-smoking women aged 40 to 74 who have at least one pre-specified high-risk factor. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Detection rate of confirmed lung cancer among screened participants
Délai: From baseline assessment through the 24-month follow-up period.
|
The primary objective is to determine the detection rate of lung cancer, with an emphasis on early-stage disease, in high-risk never-smokers undergoing LDCT screening. The analysis will estimate the rate as the number of participants with a confirmed diagnosis divided by the number of enrolled participants who underwent baseline LDCT. |
From baseline assessment through the 24-month follow-up period.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment rate
Délai: Throughout the enrollment period, ending September 2027.
|
To estimate the recruitment rate per center and per month. |
Throughout the enrollment period, ending September 2027.
|
|
Retention rate
Délai: From baseline to 24 months.
|
To estimate the retention rate between the baseline round and the 24-month follow-up assessment. |
From baseline to 24 months.
|
|
Prevalence of lung cancer detected at baseline
Délai: At baseline visit.
|
To describe the prevalence of lung cancer detected at the baseline visit. |
At baseline visit.
|
|
Incidence of lung cancer over follow-up
Délai: Over the 24-month follow-up period.
|
To describe the incidence of lung cancer over the follow-up period. |
Over the 24-month follow-up period.
|
|
Diagnostic accuracy of LDCT
Délai: Through study completion, approximately at 24 months.
|
To evaluate the diagnostic accuracy of LDCT in detecting lung cancer, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). |
Through study completion, approximately at 24 months.
|
|
Distribution of radiological findings
Délai: Through study completion, approximately at 24 months.
|
To describe the distribution of radiological findings, Lung-RADS v1.0 categories, additional procedures, referrals, and the false-positive rate. |
Through study completion, approximately at 24 months.
|
|
Characterization of diagnosed tumors
Délai: At time of diagnosis.
|
Characterize the diagnosed tumors according to clinical stage, histology, diagnostic method, and time to diagnostic confirmation. |
At time of diagnosis.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D133FR00247
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Délai de partage IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critères d'accès au partage IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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