Trial document




drksid header

  DRKS00016166

Trial Description

start of 1:1-Block title

Title

Prospective evaluation of retinal toxicity of platinum-based chemotherapy in patients with testicular cancer (RETOX-study)

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

Trial Acronym

RETOX-Study

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

URL of the Trial

http://-

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

Brief Summary in Lay Language

[---]*

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

Brief Summary in Scientific Language

According to current guidelines, men with testicular cancer may have to undergo platinum-based chemotherapy, depending on the stage of disease. Known side-effects of cisplatin include nephro- and neurotoxicity (Haugnes et al. 2012). However, visible impairment (Hillard et al. 1997; Marmor et al. 1993) and macular alterations (Kupersmith et al, Margo et al) were shown in patients who underwent cisplatin-based chemotherapy for other cancers.

In a recent pilot-study by Dulz et al (2017), our research team was able to show an association between cisplatin-based chemotherapy and subclinical retinal toxicity in patients diagnosed with testicular cancer. Morphological assessment revealed reduced retinal nerve fiber thickness in 11 of 14 patients that was also significantly correlated to the cumulative cisplatin-based chemotherapy dose. However, there was no association between the reduction of the retinal nerve fiber thickness and the time of chemotherapy which in turn implies early retinal toxicity of cisplatin-based chemotherapy.

Reduction of retinal nerve fiber thickness may become clinically relevant in upcoming age-related chronic degenerative disorders.

The aim of this study is to prospectively evaluate the retinal toxicity of platinum based chemotherapy in patients with testicular cancer.

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

  •   DRKS00016166
  •   2018/12/27
  •   [---]*
  •   yes
  •   Pending/not yet approved
  •   E142/18, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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

  •   C62 -  Malignant neoplasm of testis
  •   S04.0 -  Injury of optic nerve and pathways
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Ophthalmological examination before initiation, as well as 1, 6, and 12 months upon completion of platinum-based chemotherapy in patients diagnosed with testicular cancer.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Retinal alterations one months upon completion of platinum-based chemotherapy, defined as alterations of the retinal nerve fiber thickness in µm

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

Secondary Outcome

[---]*

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

Recruitment

  •   Planned
  •   2019/02/01
  •   72
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- patients diagnosed with testicular cancer
- indication for platinum-based chemotherapy according to current guidelines
- legal age
- written consent

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

Exclusion Criteria

- any kind of eye-disease
- minority (nonage)
- ongoing legal care
- prior chemotherapy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • gOA Uniklinik Frankfurt
    • Mr.  PD Dr.  Luis  Kluth 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • 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
    • gOA Uniklinik Frankfurt
    • Mr.  PD Dr.  Luis  Kluth 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • 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
    • gOA Uniklinik Frankfurt
    • Mr.  PD Dr.  Luis  Kluth 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • 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
    • gOA Uniklinik Frankfurt
    • Mr.  PD Dr.  Luis  Kluth 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • 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 planned
  •   [---]*
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.