Prospective Populationbased Study on Pancreatic Cancer in Stockholm- Mutation Profiling Characteristics, Biobanking and Risk Factors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
SPP study includes incidence cases of pancreatic cancer in the Stockholm county region from 2007 to 2014. The purpose of SPP study is to estimate relative risk of pancreatic cancer in relation to snuff dipping, overweight/obesity, individual food items, food groups, dietary pattern and various nutrients; to estimate relative risk of pancreatic cancer in relation to exposure to nitrosamines, either endogenously or exogenously; to estimate relative risk of pancreatic cancer in relation to oral health and H.pylori infection and their interaction with ABO blood type; to estimation relative risk of pancreatic cancer in relation to hepatitis B or hepatitis C infection; to estimate relative risk of pancreatic cancer in relation to some genetic polymorphisms, either functional or being suggested in GWAS study; to estimate mutation profile in pancreatic cancer cases, and its correlation with environmental exposures, and the impacts on survival periods in pancreatic cancer patients.
The MeSH name is Carcinoma, Pancreatic Ductal
详细描述
The SPP study is a prospective population-based case-control study. We include incident cases of pancreatic cancer in the Stockholm county region during 2008 to 2014. Controls are randomly selected from general population in the Stockholm region, and individually matched to cases by age and sex.
Cases selection. The criteria for cases selection including those are age less than 85 years, born in Sweden and presently living in the county of Stockholm. The cases of pancreatic cancer are first identified within the framework of the clinical healthcare system of the Stockholm County. Through a network, consisting of all surgical clinics and the only oncological clinic in the Stockholm county area, we were able to include a vast majority of cases diagnosed with radiological methods, he or she were asked to participate in the study. After informed consent is obtained from the patient, the study coordinator at the Karolinska University Hospital at Huddinge was notified. The coordinator will inform Statistics Sweden interviewer to interview the case patient. Further, after radiological diagnosis of pancreatic cancer, we try to retrieve a tumor biopsy for every case. In total around 30% of the cases are surgically resected and of the remaining 70% of the patients treated with a palliative intention and among which more than 80% are biopsied using fine needle aspiration (the remaining 20% not biopsied for practical reasons such as clinical deterioration), thus resulting in a total proportion of patients in which tumor tissue is retained of close to 90%.
Control selection. The control persons (non-cancer patients) are randomly identified via the Statistics Sweden. For each case, a gender- and age-matched (same birth year) control person will be identified randomly from the general population of the Stockholm County.
Data collection. Through professional interviewers from the Statistics Sweden, interviews were conducted concerning environmental factors with both cases and control persons. As soon as the study coordinator identified a case of pancreatic cancer and the patient has accepted to participate, Statistics Sweden is contacted about this patient's identify and location. Professional interviewers, blinded to the research hypotheses of the study, will then contact and go to the patient at home, at the hospital or wherever the patient is and perform the interview which is calculated to take around 1 hour and 15 minutes. The questionnaire contains items concerning demographics, socioeconomic factors, physical activity, height and weight history, tobacco and snuff use, dental health, earlier and concomitant diseases and medication history. A structured food frequency questionnaire, a modified version of a previously evaluated questionnaire, including 63 food and beverage items of interest, are used to evaluate dietary habits 20 years prior to interview.
Once a case has been identified, a set of up to 5 controls (same sex and birth year) from Stockholm general population will be selected by the Statistics Sweden. The control persons in the list are contacted by order, until a control person agrees to participate in our study. The interviewers will perform the interview in exactly the same way for the cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pancreatic cancer patients that aged less than 85 years old born in Sweden living in Stockholm
- •written informed consent
排除标准
- •pancreatic cancer older than 85 years
- •pancratic cancer younger than 18 years
- •not willing to participate
结局指标
主要结局
Survival
时间窗: 5 years
次要结局
- Factors influencing survival(5 years)
研究者
Matthias Löhr
Professor
Karolinska University Hospital
