Trial document




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  DRKS00011766

Trial Description

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Title

Registry: Fistula-associated Carcinoma in Crohn´s Disease

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Trial Acronym

FAC

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URL of the Trial

http://www.gisg.eu

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Brief Summary in Lay Language

Carcinomas associated with fistulating Crohn's disease are rare. There is only little known about risk factors that lead to their formation and possible differences with other malignant tumors. The aim of this research project is therefore to understand the risk factors and specificities of such tumors in order to be able to recognize patients with Crohn's disease more quickly in the future or to offer a better therapy to affected patients. For this purpose, medical history, existing data from MRT and CT and tumor tissue are analyzed and patients are monitored every year for 5 years.

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Brief Summary in Scientific Language

To date, little is known about fistula-associated carcinomas (FAC). Reliable data on the incidence and prevalence are hardly available. The aim of this research project is the establishment of a Germany-wide study registry for the collection of Crohn's disease patients with FACs and subsequent follow-up to characterize the disease with regard to prevalence, incidence, risk factors, prognostic factors and therapeutic responses based on the medical history, morphological, histological and molecular biology characteristics.

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Organizational Data

  •   DRKS00011766
  •   2017/05/30
  •   [---]*
  •   yes
  •   Approved
  •   EA2/155/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   Fistula-associated Carinoma in Crohn´s Disease
  •   K50 -  Crohn disease [regional enteritis]
  •   C15-C26 -  Malignant neoplasms of digestive organs
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Interventions/Observational Groups

  •   The aim of this research project is the establishment of a Germany-wide study registry for the collection of Crohn's disease patients with FACs and subsequent follow-up to characterize the disease with regard to prevalence, incidence, risk factors, prognostic factors and therapeutic responses based on the medical history, morphological, histological and molecular biology characteristics.
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Characteristics

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

Characterization of fistula-associated carcinomas

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Secondary Outcome

Regarding the presence of an FAC:

1. Analysis of image morphological parameters
2. Analysis of histological parameters
3. Analysis of molecular biology parameters

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2017/07/07
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Fistulating Crohn´s Disease , 2. Fistula-associated carcinoma (all localizations)

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Exclusion Criteria

Pre-existing carcinoma with subsequent fistula development

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Addresses

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    • German IBD Study Group (GISG)
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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    • Medizinische Klinik für Gastroenterlogie, Infektiologie und Rheumatologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin
    • Mr.  Dr. med.  Christoph  Treese 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Medizinische Klinik für Gastroenterlogie, Infektiologie und Rheumatologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin
    • Mr.  Dr. med.  Christoph  Treese 
    • Hindenburgdamm 30
    • 12200   Berlin
    • Germany
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Sources of Monetary or Material Support

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    • German IBD Study Group
    • Hopfenstraße 60
    • 24103  Kiel
    • 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.