Generation Of a Lung Biobank for Future Use
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Feasibility as a Primary Endpoint
研究概览
简要总结
The aim is to invite 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer, referred to The Royal Marsden NHS Foundation Trust (RMH) referral centres (Kingston Hospital NHS Foundation Trust, Epsom and St Helier University Hospitals NHS Trust, Croydon University Hospitals NHS Foundation Trust or St George's University Hospitals NHS Foundation Trust) over a 1 year period, to complete a life style questionnaire, document lung function tests and to donate a blood sample for storage with a view to testing for a genetic signature and other biomarkers in future studies from this established biobank.
详细描述
Patients will have been referred under the two week rule (TWR) diagnostic pathway, some will have lung cancer, others not, and other patients will have had a diagnosis of lung cancer by other pathways i.e. non TWR.
There are 3 groups of patients:
Group A - lung cancer patients at any stage and by any non TWR pathway, n=250. Group B - lung cancer patients who were referred initially by the TWR pathway, n=150.
Group C - Subjects referred by the TWR pathway (i.e. with symptoms) who do not have lung cancer, or subjects referred by any pathway who do not have lung cancer but do have radiological changes (that need follow up) or a strong family history of lung cancer, n=600.
A strong family history for this study means 1 or more first degree relatives with lung cancer with at least one individual having lung cancer at age <50 yrs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of the following criteria:
- •Patients with lung cancer at any stage or time in their disease.
- •Patients without lung cancer who have been referred by the TWR pathway.
- •Patients without lung cancer who have radiological changes on their X-Ray or CT scan that need follow up.
- •Patients without lung cancer who have a strong family history of lung cancer. PLUS
- •Patients aged >18 Years
- •Patients who have signed informed consent form
排除标准
- •Unable to provide informed consent.
- •Bleeding disorder or other medical condition that would make a blood sample hazardous.
- •Within 3 weeks of chemotherapy or radiotherapy (as low lymphocyte may be associated with poor DNA yield).
结局指标
主要结局
Feasibility as a Primary Endpoint
时间窗: 3 Years
Feasibility will be reported as the primary endpoint, where we expect 50% of patients would be willing to give a blood sample- i.e. 250/year for 2 years and thus a biobank will be established.
Create a collection of blood samples in a Biobank for Future Use
时间窗: 3 Years
The aim is to ask 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer and to create a collection of blood samples in a Biobank for Future Use.
次要结局
未报告次要终点