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

October 22, 2023 updated by: Matthias Löhr, Karolinska University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Recruiting
        • Gastrocentrum Karolinska University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthias Lohr, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Familial risk for pancreatic cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • age less than 18 yrs
  • No consensus obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI accuracy
Time Frame: Three years
MRI accuracy in detection precancerous pancreatic lesions.
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Definition of spectrum of precancerous pancreatic lesions
Time Frame: During three years
During three years
Outcome of surveillance program
Time Frame: Three years
Outcome of surveillance program analysis
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimated)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/1001-32 (Other Identifier: Swedish Ethical Board Karolinska Institutet)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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