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
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1 877-240-9479
- E-mail: information.center@astrazeneca.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Detection rate of confirmed lung cancer among screened participants
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: At time of diagnosis.
|
Characterize the diagnosed tumors according to clinical stage, histology, diagnostic method, and time to diagnostic confirmation. |
At time of diagnosis.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D133FR00247
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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.
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .