Products under Evaluation or Development
-Research and Development (R&D)-
In this section we would like to introduce the subjects we work on to help you even better in the future.
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Dr. Frank Kischkel is in charge of TherapySelects research and development, which is orientated on the development and clinical validation or evaluation of oncological diagnostic products.
Our laboratory is especially equipped for processing tumor tissue, enriching tumor cells and for measurement of primary cells. Patients' specimens are processed professionally under sterile conditions, prepared for testing and examined using special equipment.
Besides the necessary equipment, the laboratory follows requirements of quality management. The diagnostic assays, which are used for clinical studies, are adapted to the requirements of the Federal Institute for Drugs and Medical Devices (BfArM) and are standardized through SOPs (standardized operating procedure).
Our staff has completed a laboratory education on working in sterile conditions, processing primary tissue and cultivating cells and possesses adequate experiences in carrying out functional, proteinchemical and molecular-biological assays.
A constant exchange of specialized knowledge, practical experiences and latest research results is possible due to proximity to the German Cancer Research Center (DKFZ) and close cooperation with several teams from the DKFZ.
CTR-Test® - Expansion of Testable Drugs
The CTR-Test® predicts ineffective drugs with a very high probability (>95%) prior to the beginning of a chemotherapy. The method is with 17 clinical studies the best validated test-system of similar type. To provide a future-proof technology for the growing number of drugs – especially in the area of targeted drugs, further development of the test system is in progress. Based on the development new drugs will be validated. The project end will be in 2017.
The Predictor-Study examines the response of gynecological tumors to chemotherapy. The goal is to clinically validate the effectiveness of the CTR-Test®.
Short overview about the clincal trial:
- Name: The trial with the short name "Predictor-Study“ has the title "Diagnostic Precision of In-Vitro-Diagnostics for the Prediction of Response to Therapy at Patients with Ovarian Carcinoma, Tubes Carcinoma or Peritoneal Carcinomatosis“.
- Type of Study: It is a prospective, multi-center, diagnostic performance evaluation according to the German law for medical products (MPG §24, paragraph 1 sentence 2).
- Principle Investigator: The principle investigator is Prof. Dr. med. Jalid Sehouli from the gynecology of the Charité in Berlin (Germany).
- Indication: Although the indication is excepted wider, the main focus is on patients with primary, histologically-proven ovarian carcinoma, tubes carcinoma or peritoneal carcinomatosis and CA 125-concentration >70 U/ml, who will receive a chemotherapy with carboplatin and paclitaxel.
- Aim of Study: The aim encompasses more, but the primary focus is determining the precision of the prediction of response to therapy using the CTR-Test®.
- Study Arms: There is only one study arm. The patient will receive therapy independent of the tested diagnostics and 1) in accordance with other protocols accepted by the ethical committee or 2) outside clinical trials according to preferences and/or guidelines.
- Number of Patients: There were 120 patient samples sent to the laboratory. A minimum of 80 patient samples are needed for a successful trial analysis.
- Number of Centers: 34 hospitals within Germany participate in the clinical study.
- Timeframe: The Predictor-Study was started in September 2007 and was continued after a significant design change in 2011. The recruitment was finished in January 2014. The follow up is running.
- Collaborations: The Predictor-Study is conducted in collaboration with the German Cancer Research Center (DKFZ), Charité Medical University (Berlin) and Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (North-East German Society for Gynecological Oncology, NOGGO e.V.) (Link only in German).
- Funding: The project is funded by the Federal Ministery of Education and Research (BMBF) by a grant from the initiative kmu innovativ (Link only in German).