Trial document




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  DRKS00006164

Trial Description

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Title

Influence of the resection margin on survival and relapse in patients with neuroendocrine tumors of the lung.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine the required margin when performing surgical resection of the so called neuroendocrine tumors of the lung to minimize the risk of relapse but spare as much healthy lung tissue as possible.

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Brief Summary in Scientific Language

The purpose of this retrospective study is to correlate the resection margin with survival and relapse in patients that underwent surgery for neuroendocrine tumors of the lung.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006164
  •   2015/01/21
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  •   yes
  •   Approved
  •   250/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Bronchopulmonary carcinoids
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Interventions/Observational Groups

  •   Retrospective analysis of resection margins in resected bronchopulmonary carcinoids and correlation with survival and probability of recurrence of disease.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Overall survival at the time of the study. Data taken from the clinical cancer registry of the Comprehensive Cancer Center Freiburg

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Secondary Outcome

Recurrence rates at the time of the study taken from clinical reports and or telephone interview.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/01/25
  •   85
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Patients with neuroendocrine tumors of the lung (typical and atypical subtype)
2. Treated at the Dept. for Thoracic Surgery from 2003-2013
3. >18 years old
4. Written informed consent

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Mr.  PD Dr.  Jussuf  Kaifi 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Mr.  PD Dr.  Jussuf  Kaifi 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/01
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Trial Publications, Results and other Documents

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