CTC-Detect

Non-invasive diagnostic approach to determine patient risk from tumor metastasis

Non-invasive diagnostic approach to determine patient risk from tumor metastasis based on circulating tumor cells.

Description

Individual therapy success and survival rate of tumor patients depend to a large extent on whether and to what extent tumor cells have separated from the primary tumor, entered the bloodstream (circulating tumor cell = CTC) and have gained the ability to form metastases. In the CTC-Detect project, a device is being developed that can quantify CTCs via label-free detection and also measure clinically relevant tumor markers in parallel. With this system, a diagnostic approach is pursued that can detect a risk of metastasis in tumor diseases by non-invasive detection of molecular and cellular markers from patient blood.

The aim of this joint project is the development of an automated device (prototype) with the breast carcinoma as a model, which combines the enrichment of circulating tumor cells (CTC) from whole blood and the subsequent identification of the CTC and phenotyping of the cells with a multi-marker test. Recently presented studies speak for a clinical relevance of the detection of CTC in the blood, so that the detection of CTC can become an important pillar in the therapy optimization of primary and metastatic breast cancer. Persistent CTC are suitable surrogate markers for therapy resistance in the adjuvant and metastatic situation and can therefore be used as an indicator for secondary adjuvant therapy or for switching palliative therapy.

For the identification of new tumor markers and the development of new CTC assays, it is important to find biomarkers with high specificity. At present, individual tests are not sufficient for a tumor diagnosis and the degree of purity in the accumulation of CTC is still too low. New, optimized biomarkers can increase the validity of the test and thus significantly reduce the scope of testing.

As part of the research project, antibody-labeled CTCs are to be detected using a label-free detection method. Stratec has access to a novel method of label-free measurement of immunological tests. As a company with 30 years of experience in the development and production of automated systems in the in-vitro diagnostics industry, Stratec has the know-how to further develop the so-called label-free technology into a prototype reader and this prototype into a to transfer serial production.

The NMI has many years of expertise and an international reputation in the development and application of miniaturized, parallelized immunoassays for the detection of proteins from small sample quantities using microarrays. The multiplex detection of a large number of proteins from blood and also directly from tumor tissue is used in cooperation with partners from the pharmaceutical industry and clinics to identify early diagnostic and prognostic markers in drug development. In the project, the NMI is developing and optimizing a microarray chip with biochemically structured capture fields to which CTCs from blood can adhere and be quantified. In addition, the NMI is developing a multi-marker test on the adhered cells, with which CTCs can be functionally characterized and typed.

The University Women's Clinic (UFK) Tübingen provides the necessary blood samples for the development and evaluation of the device. The UFK also has the know-how of already available detection methods such as the CellSearch® system (Veridex, Johnson & Johnson) approved by the American regulatory authority (FDA), with which the performance of our new methods can be compared.

Period:
01.01.2010 - 31.08.2013
FKZ:
16SV5122

Projectlead

Dr. Markus Templin

Group Leader Cellular & Molecular Biology