REtrospective Study of TESTIcular CAncer Patients at the... | NCT02092740

Studies
REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg

NCT02092740

Sponsor

University of Magdeburg

Status

Completed

Last Update Posted

Mar 24, 2014Estimated

Enrollment

2,000Actual

Phase

Not provided

Conditions

Testicular Cancer

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 14, 2014

First Submission Date that Met QC Criteria

Mar 18, 2014

First Posted Date

Mar 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2014

Last Update Posted Date

Mar 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johann J. Wendler, MD, Dr. med. Johann Jakob Wendler, University of MagdeburgPrincipal Investigator

Lead Sponsor

University of MagdeburgOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Seminoma		Seminoma
Non-Seminoma		Non-Seminoma

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Disease-specific survival.	Disease-specific survival of testicular cancer.	Up to 52 years.
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

testicular cancer histopathologically diagnosed at the University Magdeburg Germany

Exclusion Criteria:

none.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Testicular cancer histopathologically diagnosed at the University Magdeburg 1960-2012

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johann J Wendler, Dr. Med.	Department of Urology University Magdeburg Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology University Magdeburg		Magdeburg	Saxony-Anhalt	39120	Germany

References Module

Citations

Not provided

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005834	Genital Neoplasms, Male