Testicular CancerRETESTICAPUMNCT02092740
REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg
An observational study of Testicular Cancer, run by University of Magdeburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Testicular Cancer
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Testicular cancer histopathologically diagnosed at the University Magdeburg 1960-2012
Who may be able to join
- testicular cancer histopathologically diagnosed at the University Magdeburg Germany
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Testicular Cancer
- Keywords
- Testicular cancer
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Seminoma | Seminoma | |
| Non-Seminoma | Non-Seminoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (OS).
Measured: Up to 52 years.
Secondary outcomes (9)
Disease-specific survival.
Disease-specific survival of testicular cancer.
Measured: 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
Measured: Up to 52 years.
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.
Measured: Up to 52 years.
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.
Measured: Up to 52 years.
Secondary Malignoma
Assessment of Development of Secondary malignoma after diagnosis of testicular cancer; Secondary malignoma other than testicular cancer and metachronous Primary testicular cancer
Measured: Up to 52 years.
Progressive-free survival (PFS).
Progressive-free survival (PFS).
Measured: Up to 52 years.
Relapse-free survival (RLS).
Relapse-free survival (RLS).
Measured: Up to 52 years.
Quality of Life (QoL).
Assessment of the current QoL using ECOG and EORTC-QLQ-C30-V3D.
Measured: Current situation.
Cause of death.
Cause of death.
Measured: Up to 52 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johann J. Wendler, MD, University of Magdeburg
- Investigators
- Johann J Wendler, Dr. Med., Principal investigator, Department of Urology University Magdeburg Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092740
- Sponsor's protocol ID
- DE-UKMD-URO-0023
- Acronym
- RETESTICAPUM
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Testicular Cancer Patients With Histopathological Analysis or Urological Treatment at the University Magdeburg 1960-2012.
- ClinicalTrials.gov ID
- NCT02092740
- Acronym / sponsor ID
- RETESTICAPUM / DE-UKMD-URO-0023
- Conditions
- Testicular Cancer
- Keywords
- Testicular cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seminoma | – | –Seminoma |
| Non-Seminoma | – | –Non-Seminoma |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Testicular cancer histopathologically diagnosed at the University Magdeburg 1960-2012
Key inclusion criteria (1 listed)
- testicular cancer histopathologically diagnosed at the University Magdeburg Germany
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: Up to 52 years.
Overall survival (OS).
9 secondary outcomes
Disease-specific survival.
Time frame: Up to 52 years.
Chronic side effects of testicular-cancer-specific radiation therapies.
Time frame: Up to 52 years.
Chronic side effects of testicular-cancer-specific chemotherapies.
Time frame: Up to 52 years.
Chronic side effects of testicular-cancer-specific surgical therapies.
Time frame: Up to 52 years.
Secondary Malignoma
Time frame: Up to 52 years.
Progressive-free survival (PFS).
Time frame: Up to 52 years.
Relapse-free survival (RLS).
Time frame: Up to 52 years.
Quality of Life (QoL).
Time frame: Current situation.
Cause of death.
Time frame: Up to 52 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Guidelines on testicular cancer of the European Association of Urology (EAU)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann J Wendler, Dr. Med. principal investigator
Department of Urology University Magdeburg Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 52 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.