Trial document




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  DRKS00010866

Trial Description

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Title

Prospective Study on a Plasma Metabolome Multimarker Panel MxP® PancreasScore for the Diagnosis of Pancreatic Cancer in Cohorts at Risk

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Trial Acronym

META-PAC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study, a blood test for exclusion of pancreatic cancer will be developed in high-risk groups. This risk group includes people with a chronic inflammation of the pancreas, newly diagnosed diabetes or a genetic predisposition to pancreatic cancer.
Earlier detection of pancreatic cancer would increase the survival of patients of 30-40 %. Currently no test for high risk cohorts is available.
For the study, a blood sample of 25 ml will be taken. Further interventions are not necessary.

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Brief Summary in Scientific Language

PDAC is projected to be the third leading cause of cancer-related death by 2030 due to its late diagnosis and slow progress in terms of available treatment options. An earlier diagnosis could increase the 5 year survival by as much as 30-40%. As the incidence of PDAC in subjects >50 years of age is 12/100 000, a potential surveillance would require at least two sieves to increase pretest probability, make the strategy cost-effective, and exclude PDAC in cohorts with significantly increased risk. The first sieve would select for well-defined groups with an increases PDAC risk, e.g. individuals from familial PDAC families (prevalence: 3/100 000), patients with CP (prevalence 50/100 000), or newly diagnosed onset of diabetes over the age of 50 years (prevalence 1.29/100). The second sieve would select for the metabolome signature MxP® PancreasScore identified by this consortium. It has previously been established that a new diagnostic assay for PDAC, in order to reduce health care expenditure and prolong patient survival, would have to perform with a minimum sensitivity of 88% at a specificity of 85% if the incidence is equal or above 0.71% as in newly diagnosed diabetics over the age of 50 years. The best established blood test for the diagnosis of PDAC is carbohydrate antigen 19-9 (CA19-9). Unfortunately, CA19-9 can also be elevated in patients with nonmalignant diseases. CA19-9 has been reported to discriminate between PDAC patients and healthy controls (sensitivity 80.3%, 95%CI 77.7-82.6; specificity 80.2%, 95%CI 78.0-82.3). By comparison, MxP® PancreasScore detected only 9% false positives compared to 23% for CA19-9 and identified an additional 15% of patients in whom the diagnosis of PDAC was missed when using CA19-9 alone. Thus MxP® PancreasScore exceeds the performance of CA19-9 and of the miRNA panel.
Within the PDAC project we have previously recruited 914 patients and controls for a thorough metabolomics analysis of serum and plasma samples. The existing metabolomics biomarker identification and validation pipeline of Metanomics Health uses different analytical technologies to analyze several hundreds of metabolites in a single sample. We validated a biomarker panel that distinguished PDAC from CP in the training set with an area under the curve (AUC) of 0.96 [95%CI 0.93-0.98]. At a fixed specificity of 85% the biomarker showed a sensitivity of 94.9% [95%CI 87.0-97.0]. Using the same biomarkers in the test set an AUC of 0.94 [95%CI 0.91-0.97] with a sensitivity of 89.9% [95%CI 81.0-95.5] and a specificity of 91.3% [95%CI 82.8-96.4] were achieved.

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Organizational Data

  •   DRKS00010866
  •   2016/07/28
  •   [---]*
  •   yes
  •   Approved
  •   BB 079/16, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   PANKREASRAUMFORDERUNG
  •   E10-E14 -  Diabetes mellitus
  •   C25 -  Malignant neoplasm of pancreas
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Interventions/Observational Groups

  •   In this study, a blood test for exclusion of pancreatic cancer will be developed in high-risk groups. This risk group includes people with a chronic inflammation of the pancreas, newly diagnosed diabetes or a genetic predisposition to pancreatic cancer.
    Earlier detection of pancreatic cancer would increase the survival of patients of 30-40 %. Currently no test for high risk cohorts is available.
    For the study, a blood sample of 25 ml will be taken. Further interventions are not necessary.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint of the study is the exclusion of a pancreatic cancer with high specificity in a cohort with an increased risk of pancreatic cancer and the highest possible diagnostic accuracy.

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Secondary Outcome

Secondary endpoints are a confirmed/excluded cancerous or precancerous lesions of the pancreas by imaging, histology or a minimum of 24 months follow up. Effect of tumour subtype, grading or staging (TNM), medication, dyslipidemia, thyroid dysfunction, renal insufficiency or associated diseases on MxP®PancreasScore shall be examined as well as changes in MxP®PancreasScore under treatment and during progression.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/08/17
  •   1625
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients with solid pancreatic mass lesion on imaging (abdominal CT), which requires further diagnostics (including patients with newly diagnosed diabetes (DM), familial PDAC and chronic pancreatitis (CP)
OR
diagnosis of diabetes over the age of 50 years

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Exclusion Criteria

inability to give informed consent,
pregnant or breastfeeding women,
conditions precluding surgery, biopsy or clinical follow-up justify exclusion from the study.

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Addresses

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    • Universitätsklinikum Greifswald
    • Fleischmannstraße 8
    • 17475  Greifswald
    • Germany
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    • Medizinische Klinik 2 der LMU München
    • Ms.  Prof. Dr. med  Julia   Mayerle 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Medizinische Klinik 2 der LMU München
    • Ms.  Prof. Dr. med  Julia  Mayerle 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.