Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
2011년 12월 20일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
1569
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
England
-
Cambridge, England, 영국, CB23 3RE
- Papworth Hospital
-
Coventry, England, 영국, CV2 2DX
- Walsgrave Hospital
-
Leeds, England, 영국, LS1 3EX
- Leeds General Infirmary
-
Leicester, England, 영국, LE3 9QP
- University Hospitals Of Leicester Nhs Trust
-
London, England, 영국, SW3 6NP
- Royal Brompton Hospital
-
London, England, 영국, SW10 9NH
- Chelsea Westminster Hospital
-
London, England, 영국, WC1E 5DB
- University College Hospital - London
-
Manchester, England, 영국, M23 9LT
- Wythenshawe Hospital
-
Sunderland, England, 영국, SR4 7TP
- Sunderland Royal Hospital
-
-
Northern Ireland
-
Belfast, Northern Ireland, 영국, BT9 7AB
- Respiratory Research Office Belfast City Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 제어
컨트롤 암
|
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.
|
|
다른: 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.
다른 이름들:
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of lung cancer that is diagnosed as stage I or II
기간: 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
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
기간: 5 Years
|
5 Years
|
|
Proportion of patients in the surveillance arm who have abnormal sputum cytology
기간: 5 Years
|
5 Years
|
|
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
기간: 5 Years
|
5 Years
|
|
Death from lung cancer
기간: 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)
기간: 5 Years
|
5 Years
|
|
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
기간: 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
기간: 5 Years
|
5 Years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Stephen G. Spiro, University College London Hospitals
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 8월 1일
기본 완료 (실제)
2011년 3월 1일
연구 등록 날짜
최초 제출
2007년 8월 6일
QC 기준을 충족하는 최초 제출
2007년 8월 6일
처음 게시됨 (추정)
2007년 8월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 12월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 12월 20일
마지막으로 확인됨
2011년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
폐암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)완전한피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Novartis Pharmaceuticals완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin미국, 콜롬비아, 이탈리아, 대만, 영국, 벨기에, 체코, 독일, 일본, 사우디 아라비아, 캐나다, 네덜란드, 스페인, 대한민국, 레바논, 오스트리아, 중국, 그리스, 남아프리카, 태국, 헝가리, 칠면조, 폴란드, 슬로바키아, 러시아 연방
-
SB Istanbul Education and Research Hospital아직 모집하지 않음Thryoid cancer | parathyrıoid 선종
-
Jonsson Comprehensive Cancer CenterNovartis Pharmaceuticals모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Taichung Veterans General Hospital완전한심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제대만
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Society for Endocrinology초대로 등록