Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00017455

Trial Description

start of 1:1-Block title

Title

Validation of miRNA biomarkers for the early diagnosis of lung cancer

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

[---]*

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

Brief Summary in Scientific Language

Lung cancer is one of the leading causes of death worldwide. In Germany, around 18,000 women and 34,500 men were newly diagnosed with malignant tumors of the lungs in 2012. It is the second most common cancer among men and the third most common in women, being by far the second most common cause of cancer death in Germany. Histologically, lung tumors are differentiated into 2 types, SCLC (Small Cell Lung Carcinoma) and the most common subtype NSCLC (Non-Small Cell Lung Carcinoma, with around 85%). NSCLC again differentiates between adenocarcinoma, squamous cell carcinoma and large cell lung carcinoma. Lung cancer is one of the prognostically unfavorable tumors, which is partly due to the late detection, as the symptoms and complaints, such as coughing, are relatively nonspecific.
According to one American study, more than 60% of lung cancer cases are diagnosed at late stages, with a 5-year survival rate of about 10%. In contrast, the survival rate for an early detection of the tumor is significantly higher (70%). This clearly shows the advantages of early detection of lung cancer. To date, however, the possibilities of early detection are limited, since examinations such as the MRI or CT imaging procedures, have their limitations.
Another possible approach for the early detection is the measurement of molecular biomarkers in the blood, such as microRNAs (miRNAs), also so-called "liquid biopsy". miRNAs are short-chain RNA molecules that play an important role in the regulation of cellular processes and for which disease-specific expression patterns have already been demonstrated. In preliminary studies, Hummingbird Diagnostics (HBDx) has identified a set of lung cancer-specific miRNAs in the blood.
The aim of this study is to validate and if necessary, to develop further this miRNA signature for early detection of lung cancer. The findings can help us to develop a blood test that could in long-term possibly replace a biopsy or allow earlier detection of lung tumors.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017455
  •   2019/07/23
  •   [---]*
  •   yes
  •   Approved
  •   18077, Ethik-Kommission der Bayerischen Landesärztekammer
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

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

Interventions/Observational Groups

  •   Part I: Patients, with having a potentially pathologic lung finding, will be enrolled for this study. Blood samples will be taken and a miRNA profile for the diagnosis of NSCLC will be created.

    Part II: Enrolled patients, who are diagnosed with lung cancer, will be followed up. Additional blood samples are taken to measure the therapeutic success also at the miRNA level.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Demonstration of the sensitivity and specificity of the HBDx miRNA signature for the diagnosis of NSCLC using microarray technology.

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

Secondary Outcome

Demonstrate the evidence of therapeutic success in patients with NSCLC also at the miRNA level using HBDx microarray technology

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

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

Recruitment

  •   Actual
  •   2019/06/03
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

1. Male or female patient with suspected pneumological pathology finding
2. Signed consent
3. Patient is at least 18 years old

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

Exclusion Criteria

Patient is younger than 18 years

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Hummingbird Diagnostics GmbH
    • Im Neuenheimer Feld 583
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0049 62219143310
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Hummingbird Diagnostics GmbH
    • Mr.  Dr.  Bruno  Steinkraus 
    • Im Neuenheimer Feld 583
    • 69120  Heidelberg
    • 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
    • Klinikverbund Kempten-Oberallgäu, Klinikum Immenstadt
    • Mr.  Prof. Dr. med.   Christian  Schumann 
    • Im Stillen 2-4
    • 87509  Immenstadt
    • 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
    • Hummingbird Diagnostics GmbH
    • Im Neuenheimer Feld 583
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0049 6221 9143310
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   EK Votum
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.