ISRCTN10403616
Completed
Not Applicable
Isolation of circulating tumor cells from the blood of prostate cancer patients using an antibody-coated nanodetector: An explorative mono-center non-randomized blinded trial
GILUPI GmbH (Germany)0 sites105 target enrollmentFebruary 6, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate cancer (all stages), Benign prostatic hyperplasia (all stages)
- Sponsor
- GILUPI GmbH (Germany)
- Enrollment
- 105
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Confirmed diagnosis of prostate cancer of any stage
- •2\. Written informed consent of the patient after explanation by the investigator
- •1\. Are patients which must have the diagnosis of any stages of Benign prostatic hyperplasia (BPH). But apart from this diagnosis, the patients are healthy.
- •2\. Written informed consent of the patient after explanation by the investigator
- •1\. Healthy female probands according to anamnestic and clinical criteria
- •2\. Written informed consent of the patient after explanation by the investigator
Exclusion Criteria
- •For all groups
- •1\. Age \> 18 years
- •2\. Known anaphylaxis
- •3\. 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); Immuno deficiencies: X\-linked aggamaglobulinaemia (XLA), severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), selective IgA deficiency
- •3\. Known infection with: Hepatitis A, B and C, human immunodeficiency virus (HIV), herpes simplex virus (HSV), cytomegalovirus (CMV), syphilis, toxoplasmosis, tuberculosis
- •4\. Not allowed concomitant medication: oral anticoagulants (Phenprocoumon, Coumadin), Platelet aggregation inhibitors (clopidogrel, prasugrel, ASS); recurrent thrombosis and pulmonary embolism
- •In addition for:
- •Group A: heart rhythm disturbances, clinically significant hypotension or hypovolemia
- •Group B:diagnosis prostate cancer
- •Group C: pregnancy and lactation, malignant tumour
Outcomes
Primary Outcomes
Not specified
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