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ISRCTN
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ISRCTN66203697
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ClinicalTrials.gov identifier
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Public title
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In vivo isolation of circulating tumor cells from peripheral blood of patients with breast cancer by using a structured antibody-coated nanodetector
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Scientific title
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In vivo isolation of circulating tumor cells from peripheral blood of patients with breast cancer by using a structured antibody-coated nanodetector: An explorative mono-centre non-randomised trial
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Acronym
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N/A
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Serial number at source
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CIP FSMW EpCAM-Brust-P000
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Study hypothesis
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The aim of this explorative mono-centre trial is the in vivo proof of concept. The compatibility in patients with operable breast cancer after exposure of the nanodetector in the patient vein for 30 minutes will be tested. Besides of that a performance analysis will be done. In a second group of patients with operable breast cancer a double application of the nanodetector will be performed to assess the reliability of the nanodetector after positive evaluation of the proof of concept. In parallel the antibody-based CellSearch® assay will take place to compare the in vivo isolation with the nanodetector with the FDA-approved CellSearch® method.
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Lay summary
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Lay summary under review
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Ethics approval
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The Committee on Bioethics at the Medical University, Charles Marcinkowski in Poznan approved on the 08th of April 2010 (Uchwala nr 340/10)
Clinical investigation Protocol approved on the 07th of October 2010 (Uchwala nr 834/10)
The amendment to protocol 04 approved on the 02th of December 2010 (Uchwala nr 975/10)
The amendment to protocol 05 approved on the 12th of May 2011 (Uchwala nr 416/11)
The amendment to protocol 06 approved on the 08th of September 2011 (Uchwala nr 763/11)
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Study design
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Explorative mono-centre non-randomised trial
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Countries of recruitment
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Poland
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Disease/condition/study domain
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Breast cancer (stage I-IV)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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 immunogobulin 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
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Anticipated start date
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12/05/2010
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Anticipated end date
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30/09/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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82
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Interventions
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The first group of patients will receive a single application of the nanodetector. After the complete recruitment of this group of patients a second group will be included in the study. In the second group of participants two nanodetectors will be applied under same conditions. The nanodetector will be inserted pre-operatively. Each nanodetector will be inserted in an arm vein for 30 min. To demonstrate the functionality of the nanodetector circulating tumor cells will be detected by immunocytochemistry. In parallel a blood sample will be taken from every patient before the application of the nanodetector. This blood sample will be analyzed with the CellSearch® method. At the end the data from these two methods will be compared.
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Primary outcome measure(s)
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1. Positive isolation of circulating tumorcells from peripheral blood of patients with breast cancer by using the nanodetector (proof of concept)
2. Demonstration of good biocompatibility
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Secondary outcome measure(s)
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1. Assessment of the accuracy of the nanodetector
2. Review of product-application-procedures
3. Comparision of the results with the CellSearch® method
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Sources of funding
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GILUPI GmbH (Germany)
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Trial website
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Publications
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Contact name
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Dr
Dawid
Murawa
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Address
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Ul. Garbary 15
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City/town
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Poznan
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Zip/Postcode
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61-866
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Country
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Poland
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Tel
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+48 50 548 85 85
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Email
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dmurawa@op.pl
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Sponsor
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GILUPI GmbH (Germany)
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Address
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Am Mühlenberg 11
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City/town
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Potsdam
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Zip/Postcode
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14476
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Country
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Germany
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Tel
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+49 331 5818 4786
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Fax
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+49 331 5818 4780
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Email
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stefanie.herold@gilupi.com
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Sponsor website:
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http://www.gilupi.com
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Date applied
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02/12/2011
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Last edited
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11/01/2012
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Date ISRCTN assigned
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11/01/2012
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