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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Karolinska University Hospital
Information provided by (Responsible Party):
Matthias Löhr, Karolinska University Hospital Identifier:
First received: February 14, 2014
Last updated: November 2, 2016
Last verified: November 2016

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.

Condition Intervention
Hereditary Pancreatitis
Hereditary Pancreatic Cancer
Other: MRI

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer

Resource links provided by NLM:

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • MRI accuracy [ Time Frame: Three years ]
    MRI accuracy in detection precancerous pancreatic lesions.

Secondary Outcome Measures:
  • 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

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Familial pancreatic cancer patients
Individual with ten fold higher risk to develop pancreatic cancer.
Other: MRI

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Familial risk for pancreatic cancer

Inclusion Criteria:

  • 10 fold higher risk to develop pancreatic cancer
  • Obtained informed consent

Exclusion Criteria:

  • age less than 18 yrs
  • No consensus obtained
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02078245

Contact: Matthias Löhr, Professor +46 8-585800000
Contact: Marco del Chiaro, Ass prof. +46 8-585800000

Gastrocentrum Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Matthias Löhr, Professor    08-585800000   
Contact: Marco del Chiaro, ass prof.    08-585800000   
Principal Investigator: Matthias Lohr, Professor         
Sponsors and Collaborators
Karolinska University Hospital
Principal Investigator: Marco del Chiaro, ass. prof. Karolinska University Hospital
  More Information


Responsible Party: Matthias Löhr, Professor, Karolinska University Hospital Identifier: NCT02078245     History of Changes
Other Study ID Numbers: 2010/1001-32
2010/1001-32 ( Other Identifier: Swedish Ethical Board Karolinska Institutet )
Study First Received: February 14, 2014
Last Updated: November 2, 2016

Keywords provided by Karolinska University Hospital:
Familial pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatitis, Chronic
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Agents processed this record on April 26, 2017