Trial document
DRKS00013647
Trial Description
Title
Validation of miRNA signatures for the early detection of lung cancer
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
The aim of the study is to measure markers in blood for the early detection of lung cancer. Therefore, a single blood sample is taken from a cohort of patients with suspicious X-ray or CT. This will help us to develop a blood-based test that could lead to earlier detection of lung cancer in the future and may improve survival and cure rate.
Brief Summary in Scientific Language
The aim of the study is to evaluate a novel miRNA-based methodology for the early detection of lung cancer (NSCLC) via a blood sample in a cohort of patients with suspicious X-ray or CT. The sensitivity and specificity of the marker set for the detection of lung cancer will be ascertained.
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
- DRKS00013647
- 2018/02/05
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- no
- Approved
- 159/2017, Ethik-Kommission der Universität Witten/Herdecke
Secondary IDs
- U1111-1208-7228
Health Condition or Problem studied
- C34 - Malignant neoplasm of bronchus and lung
Interventions/Observational Groups
- Blood draw from patients with suspected lung tumor
- Blood draw from patients undergoing bronchoscopic evaluation of suspected non-malignant pulmonary diseases.
Characteristics
- Non-interventional
- Other
- Non-randomized controlled trial
- Open (masking not used)
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- Other
- Diagnostic
- Parallel
- N/A
- N/A
Primary Outcome
Validation of a previously identified signature of blood-based miRNA biomarkers for the identification of lung tumors. After measuring miRNA expression levels, it will be tested whether the signature can be used to discriminate between the two cohorts and if the results are comparable to previous tests.
Secondary Outcome
Testing the potential of a previously identified signature of blood-based miRNA biomarkers for lung cancer screening.
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2018/02/12
- 303
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
1. Male or female with presumable pathological findings through X-ray/CT
2. Signed informed consent
3. Patient is at least 18 years old
Exclusion Criteria
1. History of other primary malignancies
2. Medication that influences the immune system (e.g. immunosuppressive drugs)
3. Patient is younger than 18 years
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-sponsorstart of 1:1-Block address contact primary-sponsor- 06221 9143310
- 06221 9143312
- info at hb-dx.com
- http://www.hummingbird-diagnostics.com
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinikum Konstanz Lungenzentrum / II. Medizinische Klinik
- Mr. Dr. Stephan Walterspacher
- Luisenstr. 7
- 78464 Konstanz
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 07531-801-1451
- 07531-801-1453
- stephan.walterspacher at glkn.de
- http://www.lungenzentrum-bodensee.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinikum Konstanz Lungenzentrum / II. Medizinische Klinik
- Mr. Dr. Stephan Walterspacher
- Luisenstr. 7
- 78464 Konstanz
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 07531-801-1451
- 07531-801-1453
- stephan.walterspacher at glkn.de
- http://www.lungenzentrum-bodensee.de
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- 06221 9143310
- 06221 9143312
- info at hb-dx.com
- http://www.hummingbird-diagnostics.com
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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