Trial document




drksid header

  DRKS00010069

Trial Description

start of 1:1-Block title

Title

Marker-based follow-up of patients with non muscle-invasive low/intermediate risk bladder cancer

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

Trial Acronym

UroFollow

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

In Germany, most of new bladder cancer cases are non-muscle-invasive tumours (NMIBC). After resection, this kind of tumour only rarely progresses, but 30% to 60% of these patients develop a recurrent non-muscle-invasive tumour within 3 years.
The follow-up of patients with non-muscle-invasive bladder cancer aiming at the early detection of recurrence is currently conducted by cystoscopy, which patients often experience as painful. Tumour markers, which can detect modified cellular parts in urine, could be a painless alternative, but their applicability has not yet been proven.
The clinical UroFollow trial examines whether available urine-based tumour tests are applicable for the detection of recurrent tumours in patients with non-muscle-invasive bladder cancer as compared to standard follow-up including cystoscopy.

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

Brief Summary in Scientific Language

UroFollow is the first multicentre randomized controlled Phase III trial for detection of recurrence in patients with NMIBC (pTa G1-G2) to compare FDA-approved, commercially avaliable , urine-based tumour tests (UroVysion, NMP22) and urinary cytology in a 'marker-arm' with cystoscopy in a 'usual-care arm'.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010069
  •   2016/03/22
  •   [---]*
  •   yes
  •   Approved
  •   237_15 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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

  •   pTa G1-2 bladder cancer
  •   C67 -  Malignant neoplasm of bladder
  •   D41.4 -  Neoplasm of uncertain or unknown behaviour: Bladder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Follow-up of NMIBC-patients with urine-based markers (UroVysion, NMP22) and additionally urinary cytology, ultrasound for detection of recurrence
  •   Follow-up of NMIBC-patients (Non-muscle invasive bladder cancer) with usual care (cystoscopy) for detection of recurrence
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Parallel
  •   III
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Proportion of marker-detected recurrent and progressive (muscel-invasive) bladder tumours

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

Secondary Outcome

Preventable proportion of cystoscopies due to marker results

Frequency of pains and complications (bleeding, inflammation) due to outpatient cystoscopies

Frequency and type of treatment in the usual care arm compared to current guidelines of the EAU (European Association of Urology)

Cost-benefit-comparison of follow-up

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

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/04/06
  •   260
  •   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

Completely resected primary or recurrent bladder cancer low/intermediate risk NMIBC pTa G1-2 with progression risk <5% within 3 years of follow-up, based on EORTC-risk-tables (Sylvester et al. 2006; http://www.eortc.be/tools/bladdercalculator); ECOG-status 0-2 (ambulatory, capable of self-care)

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

Exclusion Criteria

Adjuvant BCG-therapy;
Concomitant bladder carcinoma in situ;
Tumour size >3 cm;
Pregnancy;
Participation in another oncological study;
Other cancers (except of cutaneous squamous or basal cell carcinoma) within the last 5 years;
Dialysis-dependent renal insufficiency

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Forschungsstiftung Medizin am Universitätsklinikum Erlangen
    • Mr.  Prof.  Werner  Daniel 
    • Östliche Stadtmauerstr. 30a
    • 91054  Erlangen
    • 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 other
    • Urologische Klinik, Friedrich-Alexander-Universität Erlangen
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Urologie24 gGmbH
    • Mr.  Prof. Dr.  Bernd  Schmitz-Dräger 
    • Mommsenstr. 22
    • 90491  Nürnberg
    • 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
    • Urologie 24 gGmbH
    • Ms.  Dr.  Natalya  Benderska 
    • Mommsenstr.22
    • 90491  Nürnberg
    • 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
    • Forschungsstiftung Medizin am Universitätsklinikum Erlangen
    • 91054  Erlangen
    • 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 complete, follow-up continuing
  •   [---]*
end of 1:1-Block state


* This entry means the parameter is not applicable or has not been set.