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
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1 877-240-9479
- メール：information.center@astrazeneca.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Detection rate of confirmed lung cancer among screened participants
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：At time of diagnosis.
|
Characterize the diagnosed tumors according to clinical stage, histology, diagnostic method, and time to diagnostic confirmation. |
At time of diagnosis.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- D133FR00247
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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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