Clinical Trial of Pancreatic Cancer in Stockholm.

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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]


Primary Outcome

Survival

Secondary Outcome

 Factors influencing survival

Condition

Pancreatic Cancer

Intervention

Pancreatic Surgery

Study Arms / Comparison Groups

 Pancreatic cancer
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

600

Start Date

May 2007

Completion Date

February 2017

Primary Completion Date

February 2017

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
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Matthias Löhr, Professor, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT02162823

Organization ID

2006/1089-31/4

Secondary IDs

2006/1089-31/4

Responsible Party

Principal Investigator

Study Sponsor

Karolinska University Hospital


Study Sponsor

Matthias Löhr, Professor, Principal Investigator, Karolinska University Hospital


Verification Date

August 2017