REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg

Testicular Cancer Clinical Trial

— RETESTICAPUM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092740
• Other study ID #: DE-UKMD-URO-0023
• Status: Completed
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 20, 2014
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• testicular cancer histopathologically diagnosed at the University Magdeburg Germany

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Locations

Country	Name	City	State
Germany	Urology University Magdeburg	Magdeburg	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Overall survival (OS).	Up to 52 years.	No
Secondary	Disease-specific survival.	Disease-specific survival of testicular cancer.	Up to 52 years.	No
Secondary	Chronic side effects of testicular-cancer-specific radiation therapies.	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.	Yes
Secondary	Chronic side effects of testicular-cancer-specific chemotherapies.	All Therapy Associated side effects of chemotherapy using CTCAE-(Common Terminology Criteria for Adverse Events V4)-Score.	Up to 52 years.	Yes
Secondary	Chronic side effects of testicular-cancer-specific surgical therapies.	All Therapy Associated side effects of surgical therapy using CTCAE-(Common Terminology Criteria for Adverse Events V4)-Score.	Up to 52 years.	Yes
Secondary	Secondary Malignoma	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.	No
Secondary	Progressive-free survival (PFS).	Progressive-free survival (PFS).	Up to 52 years.	No
Secondary	Relapse-free survival (RLS).	Relapse-free survival (RLS).	Up to 52 years.	No
Secondary	Quality of Life (QoL).	Assessment of the current QoL using ECOG and EORTC-QLQ-C30-V3D.	Current situation.	Yes
Secondary	Cause of death.	Cause of death.	Up to 52 years.	No