Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005789

Trial Description

start of 1:1-Block title

Title

An observational retrospective/prospective study of treatment strategies for ovarian germ cell and sex cord-stromal tumors in Germany
(Current Ovarian geRm cell and SEx cord Tumor Treatment strategies)

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

Trial Acronym

CORSETT

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

[---]*

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

Brief Summary in Scientific Language

An observational, multicenter, mixed retrospective/prospective cohort study to evaluate treatment strategies for ovarian germ cell tumors (OGCT) and sex cord stromal tumors (SCST) in Germany will be conducted. In the retrospective phase of the study, a chart review of the patients with histologically confirmed OGCTs and SCSTs as identified from hospital records and/or clinical tumor registries and re-assess the histopathology reports will be performed. In the prospective phase an active follow-up for each OGCT and SCST case and collect new data on quality of life, fertility, pregnancy and sexual life will be provided.

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

Organizational Data

  •   DRKS00005789
  •   2016/02/12
  •   [---]*
  •   yes
  •   Approved
  •   513/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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

  •   C56 -  Malignant neoplasm of ovary
  •   D07.3 -  Carcinoma in situ: Other and unspecified female genital organs
  •   D39.1 -  Neoplasm of uncertain or unknown behaviour: Ovary
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Retrospective data collection:
    In the retrospective phase of the study, a chart review of the patients with histologically confirmed OGCTs and SCSTs as identified from hospital records and/or clinical tumor registries will be performed and the histopathology reports will be re-assessed.
  •   Prospective examination:
    The following questionnaires will be sent to the patient:
    1. Patient history (Fragebogen zum Krankheitsverlauf)
    2. Quality of life (EORTC QLQ-C30)
    3. Sexual life (SAQ Fallowfield, Fragebogen zur Sexualität)
    4. Anxiety and Depresssion (HADS)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   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 progression-free survival (PFS), calculated from the day of diagnosis (day of surgery, PFS and OS after relapse are calculated from the day of relapse) in relation to treatment strategies for OGCTs and SCSTs

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

Secondary Outcome

Reproductive outcomes (pregnancy rates and births), quality of life, sexual life in relation to treatment strategies for OGCTs and SCSTs.

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

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

Recruitment

  •   Actual
  •   2014/08/07
  •   400
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Female patients (any age) who were diagnosed with malignant OGCTs and SCSTs (ICD C56, D07.3 and D 39.1) or dermoid cysts with immature/malign somatic components starting from January 2001 to 2011. All centers must be able to provide paraffin embedded tumor slides for each patient for central pathology re-assessment and if possible tumor blocks.

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

Exclusion Criteria

Benign OGCTs including teratomas, benign cystic mature teratomas (dermoid cysts).

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsfrauenklinik Freiburg
    • Ms.  Prof. Dr.  Annette  Hasenburg 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • 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
    • Arbeitsgemeinschaft Gynäkologische Onkologie (AGO)
    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
    • Universitätsfrauenklinik Freiburg
    • Ms.  Prof. Dr.  Annette  Hasenburg 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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
    • Universitätsklinikum FreiburgFrauenklinik
    • Mr.  Dr.  Maximilian  Klar 
    • Hugstetter Str., 55
    • 79106  Freiburg
    • 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
    • Universitätsklinikum Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg
    • 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.