Trial document




This trial has been registered retrospectively.
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  DRKS00005376

Trial Description

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Title

Immunological and molecular Characterization of lung tumour

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Trial Acronym

MP-IL-35

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URL of the Trial

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Brief Summary in Lay Language

Lung cancer is the most frequent tumor disease world wide and is associated with a high mortality. The non-small cell lung cancer (NSCLC) represents about 85% of all bronchial carcinoma. In this category there are adenocarcinoma, squamous cell carcinoma and large-cell carcinoma. The therapy is oriented on the kind of tumor and its stadium. If possible the tumor will be removed by surgery. The further therapeutically possibilities for the treatment of the lung carcinoma consists of classical chemotherapy, radiotherapy and innovative substance classes like the tyrosinkinase-inhibitors, which inhibit either the tumor cell growth or the neoangiogenesis. Despite increasing new therapy concepts, the prognosis of the lung cancer is to date unfavourable and so far improvement of the prognosis is only moderate.
Aim of this long term research project is to understand research the immunological and molecular changes lung cancer. Afterwards these parameters will be correlated with the clinical analysis.
In the MP-IL-35 Study we plan to examine a group of about 40 patients (with lung carncer) in the time period of 24 months. At the enrollment into this study different clinical examinations will be performed on all patients and different questionnaires will be filled in including the patients content.

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Brief Summary in Scientific Language

In this prospective study, we will classify - on basis of the histo-pathological results - a molecular gen-expression of the single tumors (lung carcinoma, metastases of the lung) and compare it with each other. Further, based on the obtained data, we plan to develop a targeted therapy. From patients that underwent surgery with lung tumor biological materials (residual lung tissues and lymph nodes, bronchoalveolare lavage (BAL), blood) will be obtained. By using different methods, the tissues, the lung cells, the blood and the BAL will be analysed and immunological characterized. These analysis comprize:
d) Analysis of different cell-populations (FACS, Sorting)
e) RNA-expression analysis (microarray analysis, RT-qPCR)
f) Protein/Cytokine-analysis (ELISA), Westerblot Analysis

The characterization of the immunological signature will contribute to develop new therapy strategies.

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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

  •   DRKS00005376
  •   2013/11/13
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  •   yes
  •   Approved
  •   56_12 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Patients suspected of/or diagnosed with lung cancer:
    - before surgery: clarification, informed consent, questionnaire, EKG, spirometry, taking blood, etc.
    - intraoperative: BAL collection
    - after surgery: collection of residual tissue samples (lung, lymph nodes) from removed tissues, taking blood
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

• Identification of targeted immunotherapy for patients with lung cancer
• recurrence rate and survival (within one year)

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Secondary Outcome

• Identification of immunological and clinical parameters for early diagnosis/ prognosis of patients with lung cancer
• Characterisation of the relation between nutritional status and immun status in patients with lung cancer

Surrogate-Markers
• CD4+ T-Zellen, CD8+T-Zellen, TGFß, IL 2, IL 10, IL 12, Transthyretin level in serum, Tbet, T regulatory cells, etc.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/04/11
  •   40
  •   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

Further inclusion criteria
Patients with suspicion of/ or diagnosed lung tumor with medical indication for

1) VATS (video-assisted thoracoscopic surgery) or open surgical procedure on the lung and
2) taking blood and/or
3) performance of a bronchoscopy with bronchoalveolar lavage

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Exclusion Criteria

- limited coagulation (Quick<50%, PTT>50s, thrombocytes<100000/µl)
- limited kidney function (creatinine Kreatinin > 1,5mg/dl)
- pregnancy
- nursing period
- limited or non-existent compliance ability
- amyloidosis (SSA), family-related polyneuropathy (FAP) and family-related cardiomyopathy
- other severe diseases

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Erlangen Anästhesie Abteilung Molekulare Pneumologie
    • Ms.  Prof. Dr. Dr.  Susetta  Finotto 
    • Hartmannstraße 14
    • 91052  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen Anästhesie Abteilung Molekulare Pneumologie
    • Ms.  Prof. Dr. Dr.  Susetta  Finotto 
    • Hartmannstraße 14
    • 91052  Erlangen
    • Germany
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    • Universitätsklinikum ErlangenThoraxchirurgische Abteilung
    • Mr.  Prof. Dr.  Horia  Sirbu 
    • Krankenhausstraße 12
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Interdisziplinäres Zentrum für Klinische Forschung (IZKF), Geschäftsstelle des IZKF
    • Ms.  Dr.  Katrin  Faber 
    • Maximiliansplatz 2
    • 91054  Erlangen
    • 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.