Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy (SUPE_R)
2022年4月1日 更新者：Barbara Malene Fischer、Rigshospitalet, Denmark
Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial
The purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients.
The investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body Positron Emission Tomography combined with Computer Tomography (PET/CT) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.
研究概览
研究类型
介入性
注册 (实际的)
750
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Copenhagen、丹麦、2100
- Rigshospitalet
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Gentofte、丹麦、2900
- Gentofte Hospital
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Herlev、丹麦、2730
- Herlev Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient with non-small cell lung cancer (NSCLC), proven by cytology or histology
- Patient in clinical stages I-III
- Age≥ 18 years
- Performance status ≤ 2 at the time of referral to therapy
- Patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation).
- Patient has given his/her written informed consent before any specific procedure from protocol
Exclusion Criteria:
- Patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on CT.
- Persons deprived of liberty or under guardianship or curators
- Dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial
- Pregnant or breastfeeding women
- Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in SUPE-R. Participation in protocols related only to initial treatment will not preclude participation in SUPE-R. Cases of doubt will be settled by the steering committee.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Arm A, PET/CT
18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) replacing computed tomography (CT) at months 6, 12, 18 and 24, otherwise as B with CT scan months 9, 15 and 21.
Quality of life assessment and liquid biopsy every 3 months for later analysis.
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In the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment.
A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment.
All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months.
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无干预：Control arm B
CT-scan and clinical evaluation every 3 months.
Quality of life assessment and liquid biopsy at every 3 months for later analysis.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of relapses treatable with curative intent
大体时间：Until first detected relapse or 2 years after enrollment
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As decided by multidisciplinary meetings
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Until first detected relapse or 2 years after enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to verified relapse
大体时间：From date of randomization until the date of first documented relapse assessed up to 24 months
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Relapse verified by histology or imaging combined with MDM review
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From date of randomization until the date of first documented relapse assessed up to 24 months
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Overall survival
大体时间：From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
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Death of any course or censoring
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From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
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Overall survival for patients with relapse
大体时间：From randomization until 12 months after first detected relapse or until death (whichever comes first)
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Death of any course or censoring
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From randomization until 12 months after first detected relapse or until death (whichever comes first)
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Performance status at relapse
大体时间：From randomization until first detected relapse or 24 months
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Performance status of study participants at relapse will be assessed using Eastern Cooperative Oncology Group (ECOG) performance status scale from grade 0 to grade 4, where grade 0 corresponds to a patient who is "fully active, able to carry on all pre-disease performance without restriction" and grade 4 is a patient who is "completely disabled; cannot carry on any selfcare; totally confined to bed or chair".
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From randomization until first detected relapse or 24 months
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Quality of life / QLQ-C30
大体时间：From randomization until first detected relapse or 24 months
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Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionaire Core Questionaire 30 (EORTC QLQ-C30). The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much"). |
From randomization until first detected relapse or 24 months
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Quality of life / QLQ-LC13
大体时间：From randomization until first detected relapse or 24 months
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Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionair Lung Cancer 13 (EORTC QLQ-LC13). The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much"). |
From randomization until first detected relapse or 24 months
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Quality of life / Raw score
大体时间：From randomization until first detected relapse or 24 months
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From the results of QLQ-C30 and QLQ-LC13 a Raw Score (RS) is calculated (average of all scores) and Quality of Life is calculated as (RS - 1)/3 which outputs a value between 0 and 1, where 0 is a complete absence of symptoms and 1 is the maximum severity of all related symptoms.
This will be used for calculation of QALY in the cost-effectiveness analysis.
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From randomization until first detected relapse or 24 months
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Number of procedures to assess incidental findings
大体时间：From randomization until 24 months or first detected relapse or until death (whichever comes first)
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Procedures resulting from an incidental finding on a follow up scan
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From randomization until 24 months or first detected relapse or until death (whichever comes first)
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Types of procedures to assess incidental findings
大体时间：From randomization until 24 months or first detected relapse or until death (whichever comes first)
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Invasive / non-invasive
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From randomization until 24 months or first detected relapse or until death (whichever comes first)
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Adverse events due to invasive procedures done to assess incidental findings
大体时间：From randomization until 24 months or first detected relapse or until death (whichever comes first)
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For example: Bleeding, pneumothorax, hospital admission
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From randomization until 24 months or first detected relapse or until death (whichever comes first)
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Cost-effectiveness analysis of intervention
大体时间：From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
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Cost-effectiveness of the PET/CT regimen vs the CT regimen is assessed with the ICER (incremental cost-effectiveness ratio), i.e. the ratio of net health care costs to net QALYs ( quality-adjusted life years).
Net health care costs are estimated as the health care costs difference between the two arms and net QALYs likewise.
Health care costs are calculated from register-based information on health care consumption cumulated in 2-yrs follow-up (DRG-rates) supplemented by intervention costs based on project costs.
The relevant cost data are available at "Sundhedsdatastyrelsen" using their research service.
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From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
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Type of treatment after verification of relapse
大体时间：From randomization until 12 months after first detected relapse or until death (whichever comes first)
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Description of treatment - e.g.
surgical, radiotherapy, stereotactic ablative body radiotherapy, medical treatment
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From randomization until 12 months after first detected relapse or until death (whichever comes first)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Barbara M Fischer, MD PhD DMSci、Rigshospitalet, Denmark
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月25日
初级完成 (预期的)
2023年8月1日
研究完成 (预期的)
2026年8月1日
研究注册日期
首次提交
2018年10月25日
首先提交符合 QC 标准的
2018年11月12日
首次发布 (实际的)
2018年11月14日
研究记录更新
最后更新发布 (实际的)
2022年4月11日
上次提交的符合 QC 标准的更新
2022年4月1日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Whole body 18F-FDG PET/CT的临床试验
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Fifth Affiliated Hospital, Sun Yat-Sen University招聘中
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Peking University Cancer Hospital & Institute未知
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University of Lausanne HospitalsGeorge Coukos, MD PhD, Head of oncology招聘中
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University Hospital, Caen完全的