Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
2011年12月20日 更新者：University College, London
A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]
RATIONALE: Screening tests or exams may help doctors find lung cancer sooner, when it may be easier to treat.
PURPOSE: This randomized clinical trial is studying screening tests or exams to see how well they work compared to usual care in finding early stage lung cancer in current or past smokers with chronic obstructive pulmonary disease.
調査の概要
状態
完了
詳細な説明
OBJECTIVES:
Primary
- To show that the proportion of lung cancer diagnosed at stage I or II is significantly greater in the surveillance arm than in the control arm.
Secondary
- Establish whether sputum cytology and/or cytometry can be employed to stratify patients with chronic obstructive pulmonary disease (COPD) according to their risk of developing incidence lung cancer.
- Identify patients with pre-invasive lesions in their airways and examine the risk of developing lung cancer in patients harboring these lesions.
- Provide an opportunity to archive blood samples from patients under surveillance to enable the identification of markers of disease progression.
- Examine the compliance of regular screening among patients in this high-risk group.
- Determine the proportion of patients in which it is not possible to provide a sputum screening result.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to recruiting site, age, gender, smoking history (current vs ex-smoker) and severity of chronic obstructive pulmonary disease (COPD) (mild vs moderate). Patients are randomized to 1 of 2 arms.
- Control arm: Patients are managed according to the usual practice of their hospital or general practice for their COPD treatment. They undergo no particular investigations except those that may arise due to a change in their clinical condition. Those patients who are not diagnosed with lung cancer during the course of the study are offered a chest x-ray after 5 years of follow-up.
- Surveillance arm: Patients undergo surveillance for 5 years. A sputum sample is collected for cytology and cytometry. If the sputum sample is normal the patient is asked to provide a sputum sample annually. If the sputum sample is abnormal the patient undergoes an annual spiral CT scan followed by autofluorescence bronchoscopy. At bronchoscopy, the following samples are taken: bronchial washings, bronchial brushings, and bronchial biopsies. Bronchoscopy is repeated every 4-12 months depending upon the histology results. If an invasive lesion is found, the patient is referred for treatment via the normal hospital systems. Any remaining sputum sample is stored frozen as part of the tissue bank associated with this trial.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
研究の種類
介入
入学 (実際)
1569
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
England
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Cambridge、England、イギリス、CB23 3RE
- Papworth Hospital
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Coventry、England、イギリス、CV2 2DX
- Walsgrave Hospital
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Leeds、England、イギリス、LS1 3EX
- Leeds General Infirmary
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Leicester、England、イギリス、LE3 9QP
- University Hospitals of Leicester NHS Trust
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London、England、イギリス、SW3 6NP
- Royal Brompton Hospital
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London、England、イギリス、SW10 9NH
- Chelsea Westminster Hospital
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London、England、イギリス、WC1E 5DB
- University College Hospital - London
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Manchester、England、イギリス、M23 9LT
- Wythenshawe Hospital
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Sunderland、England、イギリス、SR4 7TP
- Sunderland Royal Hospital
-
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Northern Ireland
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Belfast、Northern Ireland、イギリス、BT9 7AB
- Respiratory Research Office Belfast City Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
DISEASE CHARACTERISTICS:
Inclusion criteria:
Meets 1 of the following criteria:
- Current smoker, defined as ≥ a 20 pack year smoking history and/or 20 year duration of smoking
- Ex-smoker who has quit smoking within the past 8 years AND has ≥ a 20 pack year smoking history and/or 20 year duration of smoking
Mild to moderate chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria
- Mild COPD: FEV_1/forced vital capacity (FVC) < 70%; FEV_1 ≥ 80% of predicted*
- Moderate COPD: FEV_1/FVC < 70%; FEV_1 50-80% of predicted* NOTE: *Spirometric values will be obtained post bronchodilator according to the recommendations in the GOLD criteria
Exclusion criteria:
- Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator)
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Life expectancy must be at least 5 years
Exclusion criteria:
- History of malignant disease within the past 5 years except non-melanomatous skin cancers
- Other serious co-morbidity
- Evidence of severe or uncontrolled systemic diseases that, in the view of the investigator, makes it undesirable for the patient to participate in this trial
- Any disorder making reliable informed consent impossible
- Unlikely to co-operate with a 5 year follow-up
PRIOR CONCURRENT THERAPY:
- Patients may receive all concurrent therapy deemed to provide adequate care as decided by their medical doctors
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：コントロール
コントロールアーム
|
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years.
This could help identify a lung cancer that may not have been associated with symptoms earlier.
|
|
他の：Surveillance
Screened arm
|
Samples tested and further interventions added if positive
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years.
This could help identify a lung cancer that may not have been associated with symptoms earlier.
The bronchial tree will be inspected first under white light and then under blue light.
All areas that appear abnormal will initially be documented and only sampled when the bronchoscopic examination has been completed.
他の名前：
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
|
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 |
|---|---|---|
|
Proportion of lung cancer that is diagnosed as stage I or II
時間枠：5 years
|
In the control arm, it is expected that only 15% of cancers will be detected early.
In the surveillance arm, we expect that at the time of the first screen, the detection rate of prevalence cancers will be about 3%, from data reported in CT screening studies
|
5 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
時間枠：5 Years
|
5 Years
|
|
Proportion of patients in the surveillance arm who have abnormal sputum cytology
時間枠：5 Years
|
5 Years
|
|
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
時間枠：5 Years
|
5 Years
|
|
Death from lung cancer
時間枠：Up to 15 years
|
Up to 15 years
|
|
Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)
時間枠：5 Years
|
5 Years
|
|
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
時間枠：5 Years
|
5 Years
|
|
Number of patients in the surveillance arm with pre-invasive lesions who develop lung cancer locally and at remote sites within the lung
時間枠：5 Years
|
5 Years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Stephen G. Spiro、University College London Hospitals
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年8月1日
一次修了 (実際)
2011年3月1日
試験登録日
最初に提出
2007年8月6日
QC基準を満たした最初の提出物
2007年8月6日
最初の投稿 (見積もり)
2007年8月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年12月21日
QC基準を満たした最後の更新が送信されました
2011年12月20日
最終確認日
2011年12月1日
詳しくは
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