Trial document




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  DRKS00010882

Trial Description

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Title

TeleBlut - individual early recognition of anaemia and polycythemia in the northern Saxony-Anhalt

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Trial Acronym

TeleBlut

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Generally, two pathological conditions may be developed in the blood – too much or too little blood. Both of these conditions may succeed in the more severe indispositions. The aim of our Study is to record the incidence of these conditions in the region of northern Saxony-Anhalt. In case of your agreement and fulfilled inclusion criteria a small amount of the capillary blood will be collected. By additional consent a small amount of the peripheral blood will also be collected. Furthermore, data on quality of life and depressive symptoms using generic questionnaires will be collected, too . Based on the data the incidence of these conditions (too much or too little blood) as well as a causal link between these conditions and depressive symptoms will be investigated and analyzed.
This data should allow us to increase our knowledge of the blood diseases as well as depression. Furthermore, we would like to point out the need of early diagnosis and therapy of these conditions.

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Brief Summary in Scientific Language

Beyond the age of 65, approximately every second human being is affected by anemia. This fact is supported by several studies and is potentially related to a massively adverse impact on mental and somatic status as well as performance. The reason for high anemia rates among aged human beings is mostly the presence of inflammatory processes, e.g. the anemia of chronic disease or myelodysplastic syndrome. On the other hand, the occurrence may follow the advanced age diseases like polycythemia vera and essential thrombocytemia. The symptoms of these diseases are often not apparent. Therefore, it should be taken into account that the number of unreported cases is much higher. These diseases may cause severe secondary complications such as deep venous thrombosis, myocardial infarction, apoplexia. Despite the above mentioned relevance there is only a little evidence about the prevalence of these diseases. At the same time, the number of healthy mutation carriers of the JAK2-V617F as well as the outcomes of these states is still not clear. Also, it remains unclear of how far the anemia causes a depression. Our study purpose is to examine these questions. The relevant number of test persons (3058) was statistically calculated. We intend to collect the capillary and peripheral blood samples and determine Vitamin B12 level, folic acid level, iron level, ferritin level, C-reactive protein and mutation analysis (JAK2, MPL, Calreticulin). Furthermore, we collect epidemiological as well as anamnestic data using generic questionnaires.
The primary aim of our study is the epidemiological investigation of the incidence of anemia and polycythemia vera in the region of northern Saxony-Anhalt. Furthermore, there are secondary aims to be achieved – analysis of anemia aetiology, incidence of the JAK2, MPL, and calreticulin mutations in healthy test persons. Also, the causal link between anemia and depressive symptoms will be investigated and analyzed. The time duration of the study is 3 years. Besides the final statistical evaluation interim analyses are intended.

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Organizational Data

  •   DRKS00010882
  •   2016/09/30
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  •   yes
  •   Approved
  •   102/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1187-9390 
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Health Condition or Problem studied

  •   D64.9 -  Anaemia, unspecified
  •   F32.9 -  Depressive episode, unspecified
  •   D45 -  Polycythaemia vera
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Interventions/Observational Groups

  •   cross-sectional survey on selected laboratory parameters and patient-reported outcomes:

    Collection of capillary and peripheral blood samples and determination of Vitamin B12 level, folic acid level, iron level, ferritin level, C-reactive protein and mutation analysis (JAK2, MPL, Calreticulin). Collection of epidemiological as well as anamnestic data using generic questionnaires.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

a) Registration of incidence of anemia and polycythemias (polycythemia vera, essential thrombocytemia, primary myelofibrosis) for 50+ aged residents of the administrative districts of the northern Saxony-Anhalt by applying the following laboratory parameters: leucocytes, erythrocytes, haemoglobin, hematocrit, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelets and differential leucocyte count

b) Aspects of health-related quality of life and depressive symptoms were assessed with SF-12 (medical outcomes study-12 Short Form Health Survey), Patient Health Questionnaire (PHQ-9), and an medical interview about lifetime and 12-month prevalence for major depression.

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Secondary Outcome

Incidence of the JAK2, MPL and calreticulin mutations particularly in healthy test persons
as well as incidence of lack of vitamin B12, folic acid and iron.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2016/10/22
  •   3058
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Resident of the administrative districts of the northern Saxony-Anhalt
2. Age 50 years and older
3. signed study consent

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Exclusion Criteria

1. Age under 50 years
2. Principal residence outside the selected administrative districts of the northern Saxony-Anhalt
3. Out- or inpatient treatment in the last 2 weeks prior to study inclusion

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Addresses

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    • Universitätsklinikum Magdeburg A.ö.R.Universitätsklinik für Hämatologie und Onkologie
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A.ö.R.Universitätsklinik für Hämatologie und Onkologie
    • Mr.  Prof. Dr. med.  Thomas  Fischer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A.ö.R.Universitätsklinik für Hämatologie und Onkologie
    • Mr.  MUDr.  Martin  Mikusko 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Wissenschaft und Wirtschaft des Landes Sachsen-Anhalt, Mitteln der Europäischen Struktur- und Investitionsfonds inder Förderperiode 2014-2020
    • City Carré Magdeburg, Hasselbachstraße 4
    • 39104  Magdeburg
    • Germany
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    •   0049 391 589 1614
    •   0049 391 589 1691
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Status

  •   Recruiting planned
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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.