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
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: AstraZeneca Clinical Study Information Center
- Puhelinnumero: 1 877-240-9479
- Sähköposti: information.center@astrazeneca.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
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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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Detection rate of confirmed lung cancer among screened participants
Aikaikkuna: From baseline assessment through the 24-month follow-up period.
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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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Recruitment rate
Aikaikkuna: Throughout the enrollment period, ending September 2027.
|
To estimate the recruitment rate per center and per month. |
Throughout the enrollment period, ending September 2027.
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Retention rate
Aikaikkuna: 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.
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Prevalence of lung cancer detected at baseline
Aikaikkuna: At baseline visit.
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To describe the prevalence of lung cancer detected at the baseline visit. |
At baseline visit.
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Incidence of lung cancer over follow-up
Aikaikkuna: Over the 24-month follow-up period.
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To describe the incidence of lung cancer over the follow-up period. |
Over the 24-month follow-up period.
|
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Diagnostic accuracy of LDCT
Aikaikkuna: Through study completion, approximately at 24 months.
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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.
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Distribution of radiological findings
Aikaikkuna: 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.
|
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Characterization of diagnosed tumors
Aikaikkuna: At time of diagnosis.
|
Characterize the diagnosed tumors according to clinical stage, histology, diagnostic method, and time to diagnostic confirmation. |
At time of diagnosis.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- D133FR00247
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
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.
IPD-jaon käyttöoikeuskriteerit
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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