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

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ClinicalTrials.gov Identifier: NCT02078245
Recruitment Status : Recruiting
First Posted : March 5, 2014
Last Update Posted : August 26, 2019
Sponsor:
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

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Detailed Description:

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 the target lesions of a clinical screening, however the concrete possibility to detect PanIN lesions during a surveillance program remain debatable and uncertain.The imaging modality technique used in the existing programs are, alone or in combination, magnetic resonance (MR), computed tomography (CT), endoscopic ultrasound (EUS), endoscopic retrograde cholagiopancreatography (ERCP). Anyway a tendency to use low aggressive modalities as MR and EUS is emerging by the recent recommendations. The results of the clinical studies are quite uncertain and difficult to compare due to different screening modalities and inclusion criteria. The yield of FPC screening programs published in literature range from 50 to 1.3%. The cost/effectiveness of a surveillance program for FPC is not already demonstrated.

The aim of this study is to analyze the preliminary result of a prospective clinical surveillance program for individuals at risk for pancreatic cancer using a low aggressive, MR based, screening.

Patients enrollment Patients with an increased "genetic" risk to develop pancreatic cancer will be enrolled in a MR surveillance program at Karolinska University Hospital.

The patients were enrolled in the study from 3 different ways: relative of probands treated for pancreas cancer at karolinska University Hospital and with a positive family history of pancreatic cancer or with a positive anamnesis of an associated genetic syndrome, subjects, with a "genetically" increased risk, referred to us from other swedish centers, subjects referred to us by general partitioners.

Inclusion criteria for the screening All the individuals with a 10 fold higher relative risk in respect to the general population to develop pancreatic cancer will be included in the study. In case of suspected known genetic syndromes, only patients with detected corresponding gene mutations will be enrolled.

Screening modalities All patients fulfilling the inclusion criteria will be enrolled in the clinical study after a specific informed consent. Basically a complete familial and personal anamensis (including the pedegree) and a clinical examination will be obtained from all the patients. A blood sample will be collected into a bio-bank at Karolinska University Hospital. An MR/MRCP with secretin will be performed for all the patients. If the result of the MR are negative (no findings detected) a one year screening, with the same modalities is recommended. Only patients with some anomaly at the MR will undergo EUS with or without FNA and/or MDCT scan. Patients with a positive anamnesis suggestive for a known genetic syndrome will be offered specific genetic tests (BRCA1/2, SPINK1, PRSS1, p16, STK11) and respective genetic counselling.

Target lesions of the screening Due to the low specificity and sensibility of the available technique in order to detect PanIN lesions, the lobulocentric atrophy areas are not considered a target of our screening. Macroscopic pre-neoplastic lesions (IPMN) or pancreatic solid mass are considered the only lesions suitable for detection and screening.


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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
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
Bloodsamples


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02078245


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

Additional Information:

Publications:

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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 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
Surveillance
Screening
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents