In vivo isolation of circulating tumor cells from peripheral blood of patients with breast cancer by using a structured antibody-coated nanodetector
- Conditions
- Breast cancer (stage I-IV)CancerMalignant neoplasm of breast
- Registration Number
- ISRCTN66203697
- Lead Sponsor
- GILUPI GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 78
1. Subjects suffering from breast 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
1. All results of laboratory tests which represent in the opinion of the auditor a risk to the participation of the patient
2. Different types of allergies (including hay fever)
3. Anaphylactic or anaphylactoid reactions
4. Each of the following autoimmune diseases: antiphospholipid syndrome (lupus anticoagulant), goodpasture's syndrome, lupus erythematosus, recurrent polychondritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, anti-neutrophil cytoplasmic antibodies (ANCA)
5. All forms of immune deficiency: X-linked agammaglobulinemia (XLA), severe combined
immunodeficiency (SCID), common variable immunodeficiency (CVID), the lack of immunoglobulin A
6. Serological diagnosis: hepatitis A, B and C, human immunodeficiency virus (HIV), herpes simplex virus (HSV), cytomegalovirus (CMV), syphilis (Wassermann positive test), toxoplasmosis, tuberculosis
7. Laboratory abnormalities of patients with a negative performance for the surgery
8. Detectable inflammatory responses
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Positive isolation of circulating tumor cells from the peripheral blood of patients with breast cancer by using the nanodetector (proof of concept)<br>2. Demonstration of good biocompatibility
- Secondary Outcome Measures
Name Time Method 1. Assessment of the accuracy of the nanodetector<br>2. Review of product application procedures<br>3. Comparision of the results with the CellSearch® method