Trial document





This trial has been registered retrospectively.
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  DRKS00017352

Trial Description

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Title

Perioperative TTV virusload in adult lung cancer patients

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Trial Acronym

TTV-RLK

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The Torque-Teno-Virus (TTV) is a ubiquitous virus with a 90% prevalence in the general population. TTV level is routinely measured in organ- as well as in lung-transplant patients. TTV is used as a marker for immunesuppression in the recipient patients.The activity of the immune system has an impact on the disease course in lung cancer patients. The aim of the study to determine the TTV level at diagnosis and during the early postoperitive period in lung cancer. We plan to include 50 lung cancer and lung nodule patients in our prospective, single center, open observational study. The TTV load will be measured from plasma both pre- and postoperatively.

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Brief Summary in Scientific Language

The Torque-Teno-Virus (TTV) is a ubiquitous virus with a 90% prevalence in the general population. TTV is a single-stranded DNA virus from the Anellovirus family. TTV leads to a slight viraemia in immunocompetent subjects. TTV is routinely measured in organ transplant patients. The TTV viraemia correlates with the activitiy of the immune sytem and can predict the organ rejection or infections. The state of the immune system is also relevant in the disease course of lung cancer. The aim of the study is to measure TTV viraemia at the time of diagnosis in lung cancer patients and to investigate the impact of surgery on TTV levels.

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Organizational Data

  •   DRKS00017352
  •   2019/07/12
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  •   yes
  •   Approved
  •   18-8539-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   D38.1 -  Neoplasm of uncertain or unknown behaviour: Trachea, bronchus and lung
  •   C34.1 -  Malignant neoplasm: Upper lobe, bronchus or lung
  •   C34.2 -  Malignant neoplasm: Middle lobe, bronchus or lung
  •   C34.3 -  Malignant neoplasm: Lower lobe, bronchus or lung
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Interventions/Observational Groups

  •   Stage I surgical resected lung cancer patients without immunesuppression; TTV (Torque-Teno-Virus) load measurement form EDTA blood preopratively, on the first and seventh postoperative days.
  •   Stage IV lung cancer patients without immunesuppression; TTV load measurement form EDTA blood.
  •   Non-malignant lung nodule patients with surgical resection without immunesuppression; TTV load measurement form EDTA blood preopratively, on the first postoperative and discharge days.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Screening
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of the study to determine the TTV level at diagnosis and during the early postoperitive period in lung cancer patients.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Stage I and IV lung cancer and non-malignant lung nodule patients

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Exclusion Criteria

immunesuppression, chemotherapy, other malignant diseases

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Addresses

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    • Ruhrlandklinik-Universitätsmedizin Essen
    • Mr.  Dr.  Dirk  Stefani 
    • Tüschener Weg
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik- Universitätsmedizin Essen
    • Mr.  Dr.  Balazs  Hegedüs 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik- Universitätsmedizin Essen
    • Mr.  Dr.  Dirk  Stefani 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Ruhrlandklinik - Universitätsmedizin Essen
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.