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Clinical Trial of Pancreatic Cancer in Stockholm. (SPP)

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ClinicalTrials.gov Identifier: NCT02162823
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Matthias Löhr, Karolinska University Hospital

Tracking Information
First Submitted Date June 11, 2014
First Posted Date June 13, 2014
Last Update Posted Date August 31, 2017
Study Start Date May 2007
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2014)
Survival [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02162823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 11, 2014)
Factors influencing survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Trial of Pancreatic Cancer in Stockholm.
Official Title Prospective Populationbased Study on Pancreatic Cancer in Stockholm- Mutation Profiling Characteristics, Biobanking and Risk Factors.
Brief Summary

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

Detailed Description

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.

For each case and control, if they agree, 20 ml of blood are collected. The samples are separated into serum and cells (red and white together) and aliquot into 4 separate serum (for subsequent protein analysis) samples and 2 cell samples after Ficoll gradient (for subsequent DNA and RNA analysis) and immediately frozen to -80°C. Control persons that decline leaving a blood sample are instead offered to leave a saliva sample, from which DNA can be extracted and analyzed.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Germline DNA and tumour DNA (PDAC patients). Saliva and urine (DNA).
Sampling Method Non-Probability Sample
Study Population Population based cohort of all patients with pancreatic cancer within the district of Stockholm and age and gender matched healthy controls.
Condition Pancreatic Cancer
Intervention Procedure: Pancreatic Surgery
Surgical removal of the pancreatic tumour (cancer) in the intervention group
Other Names:
  • Pancreatic head resection
  • Whipple procedure
  • Pancreatic resection
Study Groups/Cohorts Pancreatic cancer
Patients with pancreatic cancer and age&sex-matched controls without any cancer from a distinct population area (district of Stockholm). Patients with pancreatic cancer will be subjected to pancreatic surgery
Intervention: Procedure: Pancreatic Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2014)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • pancreatic cancer patients that aged less than 85 years old born in Sweden living in Stockholm
  • written informed consent

Exclusion Criteria:

  • pancreatic cancer older than 85 years
  • pancratic cancer younger than 18 years
  • not willing to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02162823
Other Study ID Numbers 2006/1089-31/4
2006/1089-31/4 ( Other Identifier: Swedish Ethic committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Matthias Löhr, Karolinska University Hospital
Study Sponsor Karolinska University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Matthias Löhr, Professor Karolinska University Hospital
Study Director: Magnus Nilsson, ass prof Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date August 2017