Lung cancer (non small cell lung cancer - NSCLC, stage I-IV) Cancer Malignanat neoplasm of bronchus or lung, unspecified
Conditions
Interventions
The first group of participants will receive a single application of the nanodetector. This set of subjects is the blinded part of the study. Non-cancer and lung cancer patients will be included in th
Sponsors
GILUPI GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects suffering from lung cancer (diagnosed), they are qualified for radical operation of the tumor 2. Age = 18 years 3. Results of laboratory tests are in the area that the patient is qualified to perform an operation 4. Written informed consent 5. For control group: Five subjects are non-cancer patients
Exclusion criteria
Exclusion criteria: 1. Medical history revealing psychiatric disease or any other serious diseases 2. Participating in other clinical trials 3. Any findings in physical examination that would in the opinion of the investigator make participation unsafe for the volunteer 4. Any presence or history of allergy (including hay fever) 5. Any history of anaphylactic or anaphylactoid 6. Auto immunological diseases: Anti-phospholipid antibody syndrome (lupus anticoagulant), Goodpasture's syndrome, lupus erythematosus, relapsing polychondritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, antineutrophilic cytoplasmic antibody (ANCA) 7. Immuno deficiencies: X-linked aggamaglobulinaemia (XLA), severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), selective IgA deficiency 8. Known infection with: hepatitis A, B and C, human immunodeficiency virus (HIV), herpes simplex virus (HSV), cytomegalovirus (CMV), syphilis, toxoplasmosis, tuberculosis; known illegal drug abuse 9. Changes in laboratory values with negative performance for surgery 10. Signs of inflammation reactions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Positive isolation of circulating tumor cells from peripheral blood of patients with lung cancer by using the nanodetector (proof of concept) 2. Demonstration of good biocompatibility and safety 3. Investigation of the specificity of the device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of the accuracy of the nanodetector 2. Review of product-application-procedures 3. Comparison of the results with the CellSearch® method 4. Explorative analysis of cancer related cell pathway proteins by using the CEER-Assay (Prometheus Labs) | — |
Countries
Poland
Outcome results
None listed