Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
2022年1月11日 更新者：Bristol-Myers Squibb
Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
764
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。
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
取样方法
非概率样本
研究人群
Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).
描述
Inclusion Criteria:
Cohort 1 and 2:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Cohort 3:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC not earlier than October 2013
- Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Exclusion Criteria:
- Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
Other Inclusion/Exclusion criteria may apply
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
队列和干预
团体/队列 |
|---|
|
LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
|
|
ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
|
|
relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment
|
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 |
|---|---|---|
|
Distribution of Patient Demographic Characteristics
大体时间：At baseline
|
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors |
At baseline
|
|
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
大体时间：At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
|
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
大体时间：At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
|
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
大体时间：At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
|
Distribution of treatment patterns in patients with ED-SCLC
大体时间：Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
|
Distribution of treatment patterns in patients with LD-SCLC
大体时间：Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
|
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
大体时间：Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite of SCLC-related healthcare resource utilization (HCRU)
大体时间：Approximately 44 months
|
HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
|
Approximately 44 months
|
|
Overall survival (OS)
大体时间：Approximately 44 months
|
Approximately 44 months
|
|
|
Progression-free survival (PFS)
大体时间：Approximately 44 months
|
Approximately 44 months
|
|
|
Objective response rate (ORR)
大体时间：Approximately 44 months
|
Approximately 44 months
|
|
|
Mortality rate
大体时间：Approximately 44 months
|
Approximately 44 months
|
|
|
Treatment-related adverse events (AEs) leading to discontinuation
大体时间：Approximately 44 months
|
Approximately 44 months
|
|
|
Incidence of surgery as cancer-directed therapy
大体时间：Approximately 44 months
|
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
|
Incidence of radiation therapy as cancer-directed therapy
大体时间：Approximately 44 months
|
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
|
Incidence of best supportive care (BSC)
大体时间：Approximately 44 months
|
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
|
Incidence of palliative care
大体时间：Approximately 44 months
|
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2016年12月15日
初级完成 (实际的)
2019年1月24日
研究完成 (实际的)
2019年1月24日
研究注册日期
首次提交
2017年10月13日
首先提交符合 QC 标准的
2018年2月1日
首次发布 (实际的)
2018年2月8日
研究记录更新
最后更新发布 (实际的)
2022年1月26日
上次提交的符合 QC 标准的更新
2022年1月11日
最后验证
2022年1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.