Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention (SMAC-1)
This project aims to implement a health prevention program for smokers or former smokers including early detection of lung cancer, cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD). The clinical activity is completed by a pre-clinical evaluation of molecular bio-markers of early diagnosis of these diseases, with the aim of strengthening the sensitivity and specificity of the screening program.
The project also includes a cost-effectiveness assessment to validate the feasibility of the program.
Since lung cancer, CVD and COPD are among the deadliest smoking-related pathologies, the program includes actions aimed at raising awareness among primary care physicians, increasing the smoking cessation rate of participating subjects to improve quality of life.
調査の概要
状態
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Milano
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Rozzano、Milano、イタリア、20089
- 募集
- Istituto Clinico Humanitas
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コンタクト:
- Federica Cioffi
- 電話番号:02/82247371
- メール:federica.cioffi@humanitas.it
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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 should have the following inclusion criteria:
Inclusion Criteria:
- Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
- Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
- Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
説明
Inclusion Criteria:
- Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
- Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
- Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
Exclusion Criteria:
- Previous diagnosis of lung cancer.
- Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
- Performing a chest CT scan in the last 18 months.
- Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
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
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 |
---|---|---|
To implement the screening program combining lung cancer, CVD and COPD prevention
時間枠:from 10 Oct 2018 to 10 Oct 2021
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Subjects with increased risk for lung cancer, selected through an epidemiological questionnaire, sign the informed consent and their blood is collected.
They then undergo LDCT and an interview at the anti-smoking center.
CTs presenting with at least one non-calcified nodule are managed according to dedicated diagnostic algorithm.
Nodules indicative of lung cancer will be studied with preoperative diagnosis, with surgical resection preferably performed with a minimally invasive approach.
Multimodality treatment is indicated in advanced stage of disease.
Subjects with normal findings are scheduled for annuals CT scan for two additional years.
Cardiovascular risk will be assessed with the use of the atherosclerotic cardiovascular disease (ASCVD) score, recommended by the American College of Cardiology/American Heart Association, integrated with Reynold risk score and CAC score.
The CAC score, calculated on LDCT, is used to quantify the presence of calcium through the coronary system.
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from 10 Oct 2018 to 10 Oct 2021
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Validation of circulating markers to enhance LDCT sensitivity and specificity of the screening for lung cancer, CVD and COPD early detection.
時間枠:from 10 Oct 2018 to 10 Oct 2021
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Ten ml of blood is collected before LDCT, for plasma and white blood cells. For lung cancer patients, blood is collected before treatment, at 1-6-12 months after treatment, to analyse markers for minimal residual disease or early recurrence. We will perform:
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from 10 Oct 2018 to 10 Oct 2021
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Cost benefit analysis of LC screening program
時間枠:from 10 Oct 2018 to 10 Oct 2021
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Cost-benefit analysis of the prevention program.
Direct and indirect costs associated with diagnosis and treatment of smoking-related diseases will be compared to those of a control group with disease detected after the appearance of pulmonary symptoms.
The incremental cost effectiveness ratio will be evaluated in terms of QUALYS (quality of life adjusted years saved).
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from 10 Oct 2018 to 10 Oct 2021
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
キーワード
その他の研究ID番号
- 2123
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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-
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