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临床试验/NCT03276429
NCT03276429已完成不适用

Development of an Electronic Data Base for Lung Cancer Registry Which Will Include All the Epidemiological, Clinical, Pathological, Molecular and Treatment Parameters in Lung Cancer Patients Who Are Referred to a Tertiary Oncology Unit

Oncology Center of Biochemical Education And Research1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2017年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
650
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

In the light of a new era in the management of lung cancer this non-interventional study intend to capture all the epidemiological, clinical, pathological, molecular and treatment parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a tertiary Oncology Clinic in an Electronic Data Base (EDB).

详细描述

Investigators intend to build an electronic database which will record the epidemiological, clinical, pathological, molecular data and treatment parameters of lung cancer patients (NSCLC and SCLC) who are referred to a tertiary Oncology Clinic. Documentation will include: a) Patient demographics, co- morbidities, tobacco exposure in pack-years, b) Disease related parameters: method of diagnosis, histological type, disease staging (according to 7th edition of TNM for lung cancer) and metastatic sites if any, c) Molecular status: mutation status for Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Proto-oncogene tyrosine-protein kinase ROS, Hepatocyte Growth Factor Receptor (HGFRor cMET), Human Epidermal Growth Factor Receptor 2 (HER2), proto-oncogene B-Raf, and Programmed-Death Ligand 1 (PD-L1) testing when available, d) Type of treatment (surgery, radiotherapy, chemotherapy, targeted therapies, immune-therapy), and Line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd, palliation therapy), e) Clinical outcome: Overall Survival (OS), Response Rate (RR), and Progression Free Survival (PFS).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Since this will be a non-interventional study all adult patients who will be consent for registration of their data to EDB will be enrolled.

排除标准

  • Patients with insufficient epidemiological or clinical data will be excluded such as patients with no demographic data or patients that have not taken at least 2 cycles of therapy.

结局指标

主要结局

Overall survival (OS)

时间窗: 12months

Overall Survival (OS) will be recorded for all patients and it is defined as the time in months, from diagnosis till death by any cause.

次要结局

  • Response Rate(12 months)
  • Progression Free Survival(12 months)

研究者

发起方
Oncology Center of Biochemical Education And Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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