In vivo isolation of circulating tumor cells from peripheral blood of patients with breast cancer by using a structured antibody-coated nanodetector

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN66203697

Enrollment

Registered

2012-01-11

Start date

2010-05-12

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer (stage I-IV) Cancer Malignant neoplasm of breast

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Positive isolation of circulating tumor cells from the peripheral blood of patients with breast cancer by using the nanodetector (proof of concept) 2. Demonstration of good biocompatibility	—

Secondary

Measure	Time frame
1. Assessment of the accuracy of the nanodetector 2. Review of product application procedures 3. Comparision of the results with the CellSearch® method	—

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026