Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00015762

Trial Description

start of 1:1-Block title

Title

Improvement of the quality of care through standardized documentation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Urologic tumors account for 33.2% of all cancer diseases in men and 4.2% of all
cancers of women in Germany. This explains the great importance that their healthcare data is recorded and examined under real life conditions. By documenting and analyzing the information on diagnosis, treatment and follow-up, important questions can be examined: How are patients with urological cancer treated in Germany? Which regional differences are there? How are the different forms of treatment used in the case of cancer? In addition to the goal of quality assurance, important insights can be gained: at which points and how can the treatment of cancer patients in Germany be further improved? The collection of this data is important in order to be able to name reliable figures on the care situation of cancer patients and to improve the situation of the sick with payers and politicians. Here, concrete numbers increase the willingness to support cancer patients in everyday life, in treatment and rehabilitation. The registry study is managed by the Quality Assurance Association in Uro-Oncology in Germany e.V. and coordinated by its subsidiary, d-uo-Service-GmbH, in close cooperation. The purpose of the registry study is to close knowledge gaps and thus improve the care of patients.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Urologic tumors account for 33.2% of all cancer diseases in men and 4.2% of all cancers of women in Germany. This explains the great importance that their healthcare data is recorded and examined under real life conditions. Ambulatory urologists are in Germany far predominantly responsible for the healthcare of these cancer patients. The registration of all cancers by resident urologists is needed for the cancer registry in Germany. In addition, the tumor and procedural documentation of urological malignancies in the outpatient sector can be used to answer a series of further questions: How are cancer patients in Germany treated? Which regional differences are there? What are the efficacy and side effects of medication in patients outside of clinical trials? How do patients evaluate the benefits of their respective therapy (patient reported outcome - PRO), as opposed to the efficacy tested in pivotal trials? To what extent are guidelines implemented and what are the reasons for deviations?
In addition to questions of quality assurance, standards of treatment can be analyzed, possible deficits and consequent improvement potentials can be shown. Moreover, these data on treatment reality and quality assurance can be used for the late benefit assessment, which is currently requested by many, but for which there is hardly any data basis. Furthermore, the collection and analysis of the actual state of healthcare reality is a starting point for the generation of hypotheses, which factors could have prognostic or predictive relevance for the different tumor diseases. From this, targeted therapy optimization studies can be derived.
In summary, data on ambulatory urological diagnostics, therapy and follow-up of urologic tumor diseases in Germany can generate transparency regarding the treatment reality, be used for quality assurance and hypothesis generation as well as support in the benefit assessment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015762
  •   2018/10/22
  •   [---]*
  •   yes
  •   Approved
  •   Eth-11/18, Ethik-Kommission der Ärztekammer Berlin
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   C67 -  Malignant neoplasm of bladder
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
  •   C62 -  Malignant neoplasm of testis
  •   C66 -  Malignant neoplasm of ureter
  •   C60 -  Malignant neoplasm of penis
  •   C68 -  Malignant neoplasm of other and unspecified urinary organs
  •   C65 -  Malignant neoplasm of renal pelvis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Documentation of clinical data on the history, diagnosis, findings, course of disease and therapies of patients with urological tumors
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall survival (OS) and Cancer-specific survival (CS) stratified for guideline adherence

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Number of documented patients per quarter / year and comparison with data on incidence and prevalence (Robert Koch Institute, cancer registry), recording of drug interactions / side effects for oncological drugs per quarter / year and comparison with the respective registration studies, recording of nicotine abuse and occupational noxae per new diagnosis of urothelial carcinoma, recording the number of patients reported to the second opinion centers and the number of subsequent therapy modifications. comparison of follow-up care in the practices of the association for quality assurance in
Uro-Oncology in Germany e.V. with guideline recommendations. Frequency of use of Active Surveillance and Fertility Protection.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/06/04
  •   999999
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Men and Women with verified urological cancer

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

None

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • d-uo Deutsche Uro-OnkologenInteressenverband zur Qualitätssicherung in der Uro-Onkologie in Deutschland e.V.Geschäftsstelle Berlin
    • Mr.  PD Dr. med.  Manfred  Johannsen 
    • Claire-Waldoff-Str. 3
    • 10115  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • d-uo Deutsche Uro-OnkologenInteressenverband zur Qualitätssicherung in der Uro-Onkologie in Deutschland e.V.Geschäftsstelle Berlin
    • Mr.  PD Dr. med.  Manfred  Johannsen 
    • Claire-Waldoff-Str. 3
    • 10115  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • d-uo Deutsche Uro-OnkologenInteressenverband zur Qualitätssicherung in der Uro-Onkologie in Deutschland e.V.Geschäftsstelle Berlin
    • Ms.  Elke  Hempel 
    • Claire-Waldoff-Str. 3
    • 10115  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • d-uo Deutsche Uro-OnkologenInteressenverband zur Qualitätssicherung in der Uro-Onkologie in Deutschland e.V.
    • Mr. 
    • Claire-Waldoff-Str. 3
    • 10115  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.