Isolation of circulating tumor cells from the blood of prostate cancer patients using an antibody-coated nanodetector

Completed

• Conditions: Cancer; Malignant neoplasm of prostate; Prostate cancer (all stages), Benign prostatic hyperplasia (all stages)

• Registration Number: ISRCTN10403616
• Lead Sponsor: GILUPI GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

Group A
1. Confirmed diagnosis of prostate cancer of any stage
2. Written informed consent of the patient after explanation by the investigator

Group B
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

Group C:
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Positive isolation of circulating tumor cells from peripheral blood of patients with prostate cancer by using the nanodetector (proof of concept) in comparision to patiens with BPH and healthy volonteers<br>2. Investigation of the specificity of the device

Secondary Outcome Measures

Name	Time	Method
1. Review of product-application-procedures<br>2. Comparison of the results with the CellSearch® method <br>3. Explorative analysis of cancer related cell pathway proteins by using the CEER-Assay (Prometheus Labs)