Clinical Trial: Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer

Brief Summary:

Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a positive impact in survival for patients with an increased genetic risk to develop pancreas cancer.

In this study, following the indication of the swedish guidelines, consecutive patients with a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance Imaging (MRI) based. The results of this study were analyzed looking in the patients files collected during the screening period.


Detailed Summary:

Pancreatic cancer is the 4th cause of cancer related deaths in USA and in many of the Western Countries. The incidence of the disease is almost corresponding to the mortality rate. For this reason pancreatic cancer can be considered a global lethal disease. Even if treatments have improved, the resection rate in patients suffering from ductal adenocarcinoma remain around 30% and the 5 years survival rates is below 20%. Because of the low incidence of pancreatic cancer in the general population, a population-based screening is not cost/effective. Anyway in the last two decades, data from literature demonstrate that pancreatic cancer can be the phenotypic expression of some know genetic syndromes and the existence of a familial risk to develop pancreatic cancer. In particular for this last condition, called familial pancreatic cancer (FPC), an increased risk is associated with the number of family member affected. In prospective epidemiological studies, is demonstrated that a positive family history of pancreatic cancer is present in about 10% of all consecutive probands. The identification of a population at risk, the suggestions that an early surgical treatment of pancreatic cancer can improve the prognosis and, in particular, the identifications of pre-neoplastic lesions as PanIN and IPMN associated to the natural history of FPC, contributed to the development on National and International guidelines for the surveillance of the individual at increased risk. Even do, today, no consensus is reached on inclusion criteria for a clinical surveillance program, screening modalities and target lesions. Traditionally individual with a 10 fold relative risk to develop pancreatic cancer were considered suitable for a screening program. However, more recently, the CAPS group suggested to include in a surveillance program individuals with a 5 fold higher relative risk. Early pancreatic cancer, IPMN and PanIN lesions are considered t
Sponsor: Karolinska University Hospital

Current Primary Outcome: MRI accuracy [ Time Frame: Three years ]

MRI accuracy in detection precancerous pancreatic lesions.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Definition of spectrum of precancerous pancreatic lesions [ Time Frame: During three years ]
  • Outcome of surveillance program [ Time Frame: Three years ]
    Outcome of surveillance program analysis


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: February 14, 2014
Date Started: August 2010
Date Completion: January 2025
Last Updated: November 2, 2016
Last Verified: November 2016