Trial document




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  DRKS00006871

Trial Description

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Title

Retrospective Observing Refractory Celiac Disease in Germany

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Trial Acronym

RCD-study

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URL of the Trial

http://www.gisg.eu/laufende_register-studien.html

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Brief Summary in Lay Language

The proposed study is an retrospective observational study to analyze the prevalent diagnostic and
therapeutic pathway for RCD in Germany. At the same time, a register for RCD will
be established. Another study goal is to yield an approximation of RCD incidence in
Germany.

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Brief Summary in Scientific Language

Refractory celiac disease (RCD) is a rare complication of celiac disease, being defined as an enteropathy resembling celiac disease with villous atrophy, crypt hyperplasia, but being refractory to a gluten-free diet (GFD). Refractory states can be either primary (i.e. never having responded to a GFD) or secondary, i.e. the refractory state develops after a significant time of GFD-associated clinical improvement. RCD classification is based on the biology of intraepithelial lymphocytes (IELs) found in the small intestinal lesions and includes RCD type II as an enteropathy with abberrant intraepithelial lymphocytes (IELs) that are clonal in nature and are precursors of T lymphoma cells. Contrary to type II, abberrant (clonal) IELs are not found in RCD type I. Thus, an enteropathy associated T cell lymphoma (EATL) is considered to develop in a high percentage of RCD type II, but not in RCD type I patients. Since treatment of established EATL is mostly unsuccessful and the subsequent disease course is fatal, timely establishment of RCD type II diagnosis is important to impede progression to EATL by medical treatment. However, RCD is very rare (approx. 0.5 cases per 100 celiac patients). Therefore no international diagnostic and therapeutic standard has been established yet. A nation-wide register that can be used for future diagnostic and/or therapeutic studies will allow for establishing prevalent diagnostic and therapeutic approaches for RCD in Germany as a first step towards a better treatment option for this rare condition.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006871
  •   2014/10/31
  •   [---]*
  •   yes
  •   Approved
  •   EA4/047/14, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   Refractory Celiac Disease
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Interventions/Observational Groups

  •   The proposed retrospective study is to analyze the prevalent diagnostic and therapeutic pathway for Refractory Celiac Disease (RCD) in Germany. At the same time, a register for RCD will be established.
    The data will be collected by applying the paper-bases questionnaire, including the social data of the patent, data of first diagnosis, medication, RCD diagnosis (serology, histology), nutrition therapy, clinical expression (independent on the therapy).
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Characteristics

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

The primary goal is to implement a Germany-wide Registry for Refractory Celiac Disease (RCD) patients.

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Secondary Outcome

A questionnaire based observation trial ist o be performed associated with the identification of RCD patients. Physicians, treating RCD patients, will fullfill the questionnaire containing data of the chosen diagnostic and therapeutic RCD strategy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/11/01
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria follow the criteria to diagnose RCD:
Enteropathy with villous atrophy and crypt hyperplasia (Marsh IIIa/b/c); Clinically refractory to a gluten-free diet (GFD) for >1 year; If the patient's clinical situation requires medical treatment directed to treatment of malabsorption, definition of RCD can be based on diet-refractory states <1 year:
- enteral / parenteral nutrition
- local or systemic acting steroids
- azathioprin
- other medical therapy directed towards refractory sprue

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Exclusion Criteria

Exclusion criteria:
low adherence to a GFD;
existence of other diseases, that provide an explanation for the clinical symptoms:
- Small intestinal Crohn´s disease
- Lambliasis
- Whipple´s disease
- Common variable immunodefiency (CVID)
- AIDS-associated enteropathy
- eosinophilic enteritis
- Autoimmune enteropathy
- Radiation-induced enteritis
- Intestinal tuberculosis

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Addresses

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    • CED Service GmbH
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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    • Deutsche Zöliakie-Gesellschaft e.V.
    • Ms.  Dr. med.  Stephanie  Baas 
    • Kupferstr. 36
    • 70565  Stuttgart
    • Germany
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    • Campus Benjamin Franklin der Charité - Universitätsmedizin BerlinMedizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie
    • Mr.  Dr.  Michael  Schumann 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • CED Service GmbHc/o GISG Organisationsbüro
    • Ms.  Dipl. Biol.  Karen  Schmidt 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • CED Service GmbH
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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    • Deutsche Zöliakie-Gesellschaft e.V.
    • Kupferstr. 36
    • 70565  Stuttgart
    • 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.