Trial document





This trial has been registered retrospectively.
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  DRKS00021517

Trial Description

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Title

German Registry for Marginal Zone Lymphoma and Follicular Lymphoma

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Trial Acronym

[---]*

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URL of the Trial

http://www.fl-register.de

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Brief Summary in Lay Language

These registers collect information about the lymphoma, the diagnosis made by the doctor, the treatment chosen and the outcome of the treatment. The aim is to enable the treating physicians to exchange experiences and thus to gain experience in order to provide patients with optimal care.

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Brief Summary in Scientific Language

The data available on the treatment of marginal zone lymphomas and follicular lymphomas is very diverse. Large prospective studies as a basis for evidential therapy recommendations are missing for the majority of MZoL. Thus, even in the absence of a standard therapy, the basis for planning a therapy study is missing. This basis should be created by the register data. Similarly, there is no major data available from a currently recruiting German prospective registry for the FL. Although there are more clinical prospective studies for the more frequent FL, there is no clear standard therapy, especially in the recurrence of the disease outside of studies and few data on diagnosis and treatment in everyday clinical practice.
The current register offers the chance to establish a national biobank for the relatively rare entity of the MZoL.

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

Yes

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Description IPD sharing plan:

The protocol can be made available. An application must be made for the use of the anonymised data for scientific purposes.

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Organizational Data

  •   DRKS00021517
  •   2020/05/05
  •   [---]*
  •   yes
  •   Approved
  •   103/14, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   C83 -  Non-follicular lymphoma
  •   C82 -  Follicular lymphoma
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Interventions/Observational Groups

  •   Routine examinations only.
    Time from initial diagnosis.
    Data collection:
    - Pathology
    - Diagnostics
    - Radiology
    - therapy (first line, second line, etc., maintenance, w&w, etc.)
    - Result of the therapy
    - PFS, OS
    - Stadium
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Experience in the sense of gaining knowledge on the ground of daily practice is to be gathered based on an accompanying project of the reference pathologists, which in turn contributes to quality assurance.
The existing exchange of experience within the scope of the pilot phase of the registry is to be extended and expanded to the FL, and experiences from registry activities are to be passed on promptly, which ultimately also serves the purpose of care and quality assurance.

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Secondary Outcome

The current register with the participating centres offers the chance to establish a national biobank for the relatively rare entity of the MZoL. The aim would be to establish the collection of biomaterials through the register.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/12
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Confirmation of histological diagnosis of MZoL and FL by a reference pathologist.
Consent form signed by the patient.

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Exclusion Criteria

Lack of consent.
Lack of legal capacity or insight.
Inclusion of active therapy of FL in a clinical trial.

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Addresses

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    • Universitätsklinikum Ulm
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    •   [---]*
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    • Universitätsklinikum Ulm Insitut für Experimentelle Tumorforschung
    • Mr.  Prof.  Christian  Buske 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Universitätsklinikum UlmInstitut für Experimentelle Tumorforschung
    • Ms.  Jacqueline  Gökeler 
    • James-Franck-Ring 11c (N27)
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Stiftung Deutsche Krebshilfe
    • MZoL: 
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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    • Roche Pharma AG
    • FL: 
    • Emil-Barell-Str. 1
    • 79639  Grenzach-Wyhlen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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