Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007317

Trial Description

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Title

Retrospective Analysis of Testicular Cancer Patients With Histopathological Analysis or Urological Treatment at the University Magdeburg 1960-2012.

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Trial Acronym

RETESTICAPUM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Retrospective analysis of treatment outcome and side effects of testicular cancer patients
that had been diagnosed at the University Magdeburg from 1960 until 2012.

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Brief Summary in Scientific Language

Creating an ACCESS Windows form based Data Registry for testicular cancer patients.

Relevant data for testicular cancer patients based on EAU-guidelines 2013 and EORTC/RTOG,
Lent-SOMA, CTC. All testicular cancer patients who had been histopathologically diagnosed al
the Institute of Pathology at the University Magdeburg. About 2000 patients from 1960 until
2012. Postgraduate students collecting data requesting hospital documents, cancer registry
of Sachsen-Anhalt, family practitioners and urologists as well as patients. Statistically
Analysis with ACCESS and IBM SPSS statistics.

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Organizational Data

  •   DRKS00007317
  •   2016/03/11
  •   2014/03/14
  •   yes
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Secondary IDs

  •   NCT02092740  (ClinicalTrials.gov)
  •   DE-UKMD-URO-0023  (University of Magdeburg)
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Health Condition or Problem studied

  •   Testicular Cancer
  •   C62 -  Malignant neoplasm of testis
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Overall survival (OS); time frame: Up to 52 years.; Overall survival (OS).

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Secondary Outcome

- Disease-specific survival.; time frame: Up to 52 years.; Disease-specific survival of testicular cancer.
- Chronic side effects of testicular-cancer-specific radiation therapies.; time frame: Up to 52 years.; All Therapy Associated side effects of radiation therapy using EORTC (European Organisation for Research and Treatment of Cancer) /RTOG- (Radiation Therapy Oncology Group) - RTOG/EORTC Late Radiation Morbidity Scoring Schema), LENT-SOMA-(Late Effects of Normal Tissues)-, CTCAE-(Common Terminology Criteria for Adverse Events V4)-Scores. See
- Chronic side effects of testicular-cancer-specific chemotherapies.; time frame: Up to 52 years.; All Therapy Associated side effects of chemotherapy using CTCAE-(Common Terminology Criteria for Adverse Events V4)-Score.
- Chronic side effects of testicular-cancer-specific surgical therapies.; time frame: Up to 52 years.; All Therapy Associated side effects of surgical therapy using CTCAE-(Common Terminology Criteria for Adverse Events V4)-Score.
- Secondary Malignoma; time frame: Up to 52 years.; Assessment of Development of Secondary malignoma after diagnosis of testicular cancer; Secondary malignoma other than testicular cancer and metachronous Primary testicular cancer
- Progressive-free survival (PFS).; time frame: Up to 52 years.; Progressive-free survival (PFS).
- Relapse-free survival (RLS).; time frame: Up to 52 years.; Relapse-free survival (RLS).
- Quality of Life (QoL).; time frame: Current situation.; Assessment of the current QoL using ECOG and EORTC-QLQ-C30-V3D.
- Cause of death.; time frame: Up to 52 years.; Cause of death.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/11/30
  •   2000
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Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- testicular cancer histopathologically diagnosed at the University Magdeburg Germany

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Exclusion Criteria

- none.

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Addresses

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    • University of Magdeburg
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    • Department of Urology University Magdeburg Germany
    • Johann J Wendler, Dr. Med. 
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    • Department of Urology University Magdeburg Germany
    • Johann J Wendler, Dr. Med. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05


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