Trial document




drksid header

  DRKS00005415

Trial Description

start of 1:1-Block title

Title

Differentiation of pulmonary cytokines and purinergic molecules with potential prognostic value and immunomodulatory properties in non-small cell lung cancer patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

There is an abundance of messenger molecules that play a role in cancerous disease. A main group of messenger proteins are the so called cytokines, which play an important role in the interaction of cells in the immunosystem in cancerous disease as well as in infections and or inflammatory processes. In this study we would like to focus on CCL18. Similar effects have been shown for Adenosintriphosphate (ATP), which is a part of the so called purinergic signaling, a form of extracellular signaling mediated by purine nucleotides and nucleosides. For both molekules there has been evidence that they have an influence on the reaction of the immunosystem on malignant cells. For example ATP concentrations in the tumor environment are usually high and ATP has been shown to induce tumor cell death. However this function is not carried out as ATP is degraded quickly by other physiologic proteins thus suppressing this function. For CCL18 there has been evidence to influence cells of the immunosystem creating a tolerogenic tumor environment, meaning an environment in which the body does not attack the malignant cells. The aim of this study is to analyze these molecules and their associated messengers which give information about the cellular interactions in bronchoalveolar lavage (small amounts of fluid are instilled in the affected parts of the lung and directly withdrawn by suction) of patients suffering from non-small-cell lung cancer to create a better understanding of the immunologic setting and thus in the long run possibly creating new therapeutic options.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Purinergic signaling has been studied in many in vitro studies to date. There was evidence that it has an important function in the tumor environment where it carries out cytotoxic as well as anti-angiogenetic properties. At the same time there is evidence that the body reacts by inducing so called ectonucleotideses (CD39 and CD73) and thus suppresses these effects.
Another focus of this study is the cytokine CCL18. There has been recent evidence of an influence on an tolerogenic setting within the tumor environment by influencing tumor associated makrophages and T-helper cells. Furthermore CCL18 in serum has been shown to be a prognostic marker for non-small-cell lung cancer. Thus the aim of the is study is to measure the above mentioned molecules and their associated cytokines in bronchoalveolar lavages of patients with non-small-cell lung cancer and correlate them with clinical markers. In a next step the aim is to analyze the tumor environment on a cellular level as well and thus create potential new therapeutical possibilites.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005415
  •   2013/11/08
  •   [---]*
  •   yes
  •   Approved
  •   440/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1149-6752 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Bronchoalveolar lavages are taken from patients with either proven or suspected non-small-cell lung cancer and directly analyzed for ATP concentrations. Cells and bronchoalveolar lavage fluid are frozen down to later be analyzed for RNA and cytokines.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Measurement of ATP directly after sample acquisition.
Measurement of cytokines via ELISA and RNA via qPCR after completion of patient recruitment.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

None

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/11/15
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with suspected or proven non-small-cell lung cancer

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Other malignant disease, other lung disease like asthma, sarcoidosis, fibrosis (not COPD), acute systemic or pulmonary infection, patients undergoing chemotherapie, immunosuppressive therapy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum FreiburgDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum FreiburgDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg
    • Hugstetter Straße 49
    • 79095  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.