REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg (RETESTICAPUM)

March 20, 2014 updated by: Johann J. Wendler, MD, University of Magdeburg

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Urology University Magdeburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Testicular cancer histopathologically diagnosed at the University Magdeburg 1960-2012

Description

Inclusion Criteria:

  • testicular cancer histopathologically diagnosed at the University Magdeburg Germany

Exclusion Criteria:

  • none.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Seminoma
Non-Seminoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 52 years.
Overall survival (OS).
Up to 52 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific survival.
Time Frame: Up to 52 years.
Disease-specific survival of testicular cancer.
Up to 52 years.
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
Up to 52 years.
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.
Up to 52 years.
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.
Up to 52 years.
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
Up to 52 years.
Progressive-free survival (PFS).
Time Frame: Up to 52 years.
Progressive-free survival (PFS).
Up to 52 years.
Relapse-free survival (RLS).
Time Frame: Up to 52 years.
Relapse-free survival (RLS).
Up to 52 years.
Quality of Life (QoL).
Time Frame: Current situation.
Assessment of the current QoL using ECOG and EORTC-QLQ-C30-V3D.
Current situation.
Cause of death.
Time Frame: Up to 52 years.
Cause of death.
Up to 52 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Investigators

  • Principal Investigator: Johann J Wendler, Dr. Med., Department of Urology University Magdeburg Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-UKMD-URO-0023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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