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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.
Verified November 2016 by Matthias Löhr, Karolinska University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02078245
First Posted: March 5, 2014
Last Update Posted: November 3, 2016
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.
Information provided by (Responsible Party):
Matthias Löhr, Karolinska University Hospital
  Purpose

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 Matthias Löhr, 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
Bloodsamples

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
MRI

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT02078245


Contacts
Contact: Matthias Löhr, Professor +46 8-585800000 matthias.lohr@ki.se
Contact: Marco del Chiaro, Ass prof. +46 8-585800000 marco.del-chiaro@karolinska.se

Locations
Sweden
Gastrocentrum Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Matthias Löhr, Professor    08-585800000    matthias.lohr@ki.se   
Contact: Marco del Chiaro, ass prof.    08-585800000    marco.del-chiaro@karolinska.se   
Principal Investigator: Matthias Lohr, Professor         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Marco del Chiaro, ass. prof. Karolinska University Hospital
  More Information

Publications:

Responsible Party: Matthias Löhr, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02078245     History of Changes
Other Study ID Numbers: 2010/1001-32
2010/1001-32 ( Other Identifier: Swedish Ethical Board Karolinska Institutet )
First Submitted: February 14, 2014
First Posted: March 5, 2014
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by Matthias Löhr, Karolinska University Hospital:
Familial pancreatic cancer
Surveillance
Screening

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatitis
Pancreatitis, Chronic
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents