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 March 2014 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Matthias Löhr, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT02078245
First received: February 14, 2014
Last updated: March 4, 2014
Last verified: March 2014
  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 Karolinska University Hospital:

Primary Outcome Measures:
  • MRI accuracy [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
    MRI accuracy in detection precancerous pancreatic lesions.


Secondary Outcome Measures:
  • Definition of spectrum of precancerous pancreatic lesions [ Time Frame: During three years ] [ Designated as safety issue: Yes ]
  • Outcome of surveillance program [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Study First Received: February 14, 2014
Last Updated: March 4, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014