Trial document




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  DRKS00013750

Trial Description

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Title

Prospective, longitudinal, observational study of novel serum/plasma biomarkers of disease activity in patients with inflammatory bowel disease

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Identifikation of blood values to facilitate the management of chronic inflammatory bowel diseases during therapy. The results will be compared with those from a group of healthy volunteers.

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Brief Summary in Scientific Language

Identification of serum biomarkers to aid the monitoring of disease activity in patients with inflammatory bowel disease

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Organizational Data

  •   DRKS00013750
  •   2018/03/22
  •   [---]*
  •   yes
  •   Approved
  •   7766_BO_K_2018, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1211-2284 
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Health Condition or Problem studied

  •   K50 -  Crohn disease [regional enteritis]
  •   K51 -  Ulcerative colitis
  •   K52 -  Other noninfective gastroenteritis and colitis
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Interventions/Observational Groups

  •   Patients with chronic inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis, Microscopic colitis), in whom a new anti-inflammatory treatment is started in routine management. Before therapy start and at 2-3 follow-up time points, blood samples are taken in addition to routine samples to determine the levels of candidate biomarkers, which are then correlated to disease activity.
  •   Historic measurements from healthy volunteers are already available.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Changes in biomarkers (laboratory analysis, serum samples) in patients who respond to treatment vs. non-responders and controls

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Secondary Outcome

Time to reach the change in biomarkers with respect to therapeutic goals

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/04/01
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

- Outpatient visit for study-independent medical reasons
- Patients with a) Crohn's disease, b) Ulcerative Colitis, c) Microscopic colitis
- Patients before therapy start with an (extended) anti-inflammatory treatment (5-ASA, Budesonid, Prednisolon, Azathioprin, Methotrexat, anti-TNF, Vedolizumab, Ustekinumab, Tofacitinib)

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Exclusion Criteria

- Stoma
- Diseases which prevent the patient from understanding the nature and the concept of the clinical trial
- Indications that the patient will presumably not comply with the protocol (e.g. adherence problem)

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • MHH OE6810
    • Mr.  PD Dr. med.  Oliver  Bachmann 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • MHH OE6810
    • Mr.  PD Dr. med.  Oliver  Bachmann 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover OE6810
    • Mr.  PD Dr. med.  Oliver  Bachmann 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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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.