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RETESTICAPUM: REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg

Sponsor
University of Magdeburg (Other)
Overall Status
Completed
CT.gov ID
NCT02092740
Collaborator
(none)
2,000
Enrollment
1
Location
30
Duration (Days)
2029.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Analysis of Testicular Cancer Patients With Histopathological Analysis or Urological Treatment at the University Magdeburg 1960-2012.
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Seminoma

    Seminoma
    Non-Seminoma

    Non-Seminoma

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [Up to 52 years.]

      Overall survival (OS).

    Secondary Outcome Measures

    1. Disease-specific survival. [Up to 52 years.]

      Disease-specific survival of testicular cancer.

    2. Chronic side effects of testicular-cancer-specific radiation therapies. [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

    3. Chronic side effects of testicular-cancer-specific chemotherapies. [Up to 52 years.]

      All Therapy Associated side effects of chemotherapy using CTCAE-(Common Terminology Criteria for Adverse Events V4)-Score.

    4. Chronic side effects of testicular-cancer-specific surgical therapies. [Up to 52 years.]

      All Therapy Associated side effects of surgical therapy using CTCAE-(Common Terminology Criteria for Adverse Events V4)-Score.

    5. Secondary Malignoma [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

    6. Progressive-free survival (PFS). [Up to 52 years.]

      Progressive-free survival (PFS).

    7. Relapse-free survival (RLS). [Up to 52 years.]

      Relapse-free survival (RLS).

    8. Quality of Life (QoL). [Current situation.]

      Assessment of the current QoL using ECOG and EORTC-QLQ-C30-V3D.

    9. Cause of death. [Up to 52 years.]

      Cause of death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • testicular cancer histopathologically diagnosed at the University Magdeburg Germany
    Exclusion Criteria:
    • none.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology University Magdeburg Magdeburg Sachsen-Anhalt Germany 39120

    Sponsors and Collaborators

    • University of Magdeburg

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johann J. Wendler, MD, Dr. med. Johann Jakob Wendler, University of Magdeburg
    ClinicalTrials.gov Identifier:
    NCT02092740
    Other Study ID Numbers:
    • DE-UKMD-URO-0023
    First Posted:
    Mar 20, 2014
    Last Update Posted:
    Mar 24, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Johann J. Wendler, MD, Dr. med. Johann Jakob Wendler, University of Magdeburg
    Testicular cancer
    Additional relevant MeSH terms:
    Testicular Neoplasms

    Study Results

    No Results Posted as of Mar 24, 2014