- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04315766
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.
연구 개요
상태
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Milano
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Rozzano, Milano, 이탈리아, 20089
- 모병
- Istituto Clinico Humanitas
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연락하다:
- Federica Cioffi
- 전화번호: 02/82247371
- 이메일: federica.cioffi@humanitas.it
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To implement the screening program combining lung cancer, CVD and COPD prevention
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Validation of circulating markers to enhance LDCT sensitivity and specificity of the screening for lung cancer, CVD and COPD early detection.
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2123
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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