NCT02162823

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

9.8 years

First QC Date

June 11, 2014

Last Update Submit

October 22, 2023

Conditions

Keywords

The MeSH name is Carcinoma, Pancreatic Ductal

Outcome Measures

Primary Outcomes (1)

  • Survival

    5 years

Secondary Outcomes (1)

  • Factors influencing survival

    5 years

Study Arms (1)

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

Procedure: Pancreatic Surgery

Interventions

Surgical removal of the pancreatic tumour (cancer) in the intervention group

Also known as: Pancreatic head resection, Whipple procedure, Pancreatic resection
Pancreatic cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • pancreatic cancer older than 85 years
  • pancratic cancer younger than 18 years
  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Gastrocentrum

Stockholm, 14186, Sweden

Location

Related Publications (4)

  • Yu J, Song H, Ekheden I, Lohr M, Ploner A, Ye W. Gastric Mucosal Abnormality and Risk of Pancreatic Cancer: A Population-Based Gastric Biopsy Cohort Study in Sweden. Cancer Epidemiol Biomarkers Prev. 2021 Nov;30(11):2088-2095. doi: 10.1158/1055-9965.EPI-21-0580. Epub 2021 Sep 8.

  • Molina-Montes E, Van Hoogstraten L, Gomez-Rubio P, Lohr M, Sharp L, Molero X, Marquez M, Michalski CW, Farre A, Perea J, O'Rorke M, Greenhalf W, Ilzarbe L, Tardon A, Gress TM, Barbera VM, Crnogorac-Jurcevic T, Munoz-Bellvis L, Dominguez-Munoz E, Balsells J, Costello E, Iglesias M, Kleeff J, Kong B, Mora J, O'Driscoll D, Poves I, Scarpa A, Yu J, Ye W, Hidalgo M, Carrato A, Lawlor R, Real FX, Malats N; PanGenEU Study Investigators. Pancreatic Cancer Risk in Relation to Lifetime Smoking Patterns, Tobacco Type, and Dose-Response Relationships. Cancer Epidemiol Biomarkers Prev. 2020 May;29(5):1009-1018. doi: 10.1158/1055-9965.EPI-19-1027. Epub 2020 Feb 12.

  • Yu J, Ploner A, Kordes M, Lohr M, Nilsson M, de Maturana MEL, Estudillo L, Renz H, Carrato A, Molero X, Real FX, Malats N, Ye W. Plasma protein biomarkers for early detection of pancreatic ductal adenocarcinoma. Int J Cancer. 2021 Apr 15;148(8):2048-2058. doi: 10.1002/ijc.33464. Epub 2021 Jan 15.

  • Molina-Montes E, Coscia C, Gomez-Rubio P, Fernandez A, Boenink R, Rava M, Marquez M, Molero X, Lohr M, Sharp L, Michalski CW, Farre A, Perea J, O'Rorke M, Greenhalf W, Iglesias M, Tardon A, Gress TM, Barbera VM, Crnogorac-Jurcevic T, Munoz-Bellvis L, Dominguez-Munoz JE, Renz H, Balcells J, Costello E, Ilzarbe L, Kleeff J, Kong B, Mora J, O'Driscoll D, Poves I, Scarpa A, Yu J, Hidalgo M, Lawlor RT, Ye W, Carrato A, Real FX, Malats N; PanGenEU Study Investigators. Deciphering the complex interplay between pancreatic cancer, diabetes mellitus subtypes and obesity/BMI through causal inference and mediation analyses. Gut. 2021 Feb;70(2):319-329. doi: 10.1136/gutjnl-2019-319990. Epub 2020 May 14.

Biospecimen

Retention: SAMPLES WITH DNA

Germline DNA and tumour DNA (PDAC patients). Saliva and urine (DNA).

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Matthias Löhr, Professor

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR
  • Magnus Nilsson, ass prof

    Karolinska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 13, 2014

Study Start

May 1, 2007

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations