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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02078245
Recruitment Status : Recruiting
First Posted : March 5, 2014
Last Update Posted : August 26, 2019
Information provided by (Responsible Party):
Matthias Löhr, Karolinska University Hospital

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.

Condition or disease Intervention/treatment
Hereditary Pancreatitis Hereditary Pancreatic Cancer Other: MRI

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
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
Actual Study Start Date : August 2010
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Group/Cohort Intervention/treatment
Familial pancreatic cancer patients
Individual with ten fold higher risk to develop pancreatic cancer.
Other: MRI

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

Secondary Outcome Measures :
  1. Definition of spectrum of precancerous pancreatic lesions [ Time Frame: During three years ]
  2. Outcome of surveillance program [ Time Frame: Three years ]
    Outcome of surveillance program analysis

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02078245

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

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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
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Principal Investigator: Marco del Chiaro, ass. prof. Karolinska University Hospital

Additional Information:


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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 )
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Keywords provided by Matthias Löhr, Karolinska University Hospital:
Familial pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatitis, Chronic
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents