As part of the rapid clinical implementation process through NCT MASTER, the NCT POP “Individual Patient” program (S. Fröhling, C. Heining, H. Glimm) enrolls patients with particularly challenging advanced cancers as well as surprise responders to undergo cancer genome sequencing with a focus on leveraging the expertise of multiple NCT/HUMS departments to identify rational treatment options. The current workflow achieves a 6-8 week turnaround time from sample acquisition to clinical evaluation.
NCT promotes swift translation of innovative high-throughput diagnostics into clinical practice.
Cases are discussed in a dedicated molecular tumor board (NCT Tumorboard “Personalisierte Onkologie”) consisting of physician-scientists, translational oncologists, bioinformaticians, molecular biologists and pathologists. Approximately 30 percent of patients analyzed to date showed molecular alterations amenable to targeted therapies, such as BRAF inhibition in refractory hairy-cell leukemia (Dietrich N Engl J Med 2012). We will extend the “Individual Patient” protocol for adult cancer patients within the NCT-MASTER 2014 trial to include all adult patients at NCT/HUMS with advanced-stage cancers who are younger than 50 years.
Strategic projects for 2014 also include the nationwide INFORM study, coordinated by O. Witt, P. Lichter and S. Pfister, which aims to enroll all children and adolescents with relapsed or refractory cancers in Germany to systematically enable personalized treatment based on comprehensive molecular profiling of individual tumors.
Additionally, the Program for Anti-Cancer Targets (PACT) expedites clinical trials at the NCT in collaboration with industry partners to improve the access of cancer patients to better diagnose, treat and cure cancer. The program, initiated 2013, envisions reducing the burden of cancer by supporting the investigational use of novel diagnostics methodology and anticancer agents.
Within the program we support translational approaches of oncology research by establishing a specialized interface for NCT/DKFZ – Industry collaborations. Via this interface, PACT provides access to agents for anti-tumor screening, and drug candidates currently in clinical testing, thereby enabling rapid translation of basic research findings into clinical trials and patient care. PACT accomplishes its mission by administering, coordinating, and funding clinical trials, as well as sponsoring other clinical research to evaluate new anti-cancer agents.
The NCT Program for Ethics and Patient-oriented care (NCT-EPOC) currently aligns the informed consent process to patients’ and providers’ needs and periodically updates a Code of Conduct for handling genetic information. It is closely linked to the interdisciplinary EURAT project in Heidelberg (Ethical and legal aspects of whole genome sequencing). EURAT addresses normative questions and aims at developing an ethically and legally informed practice for genomic research in Heidelberg. Therefore EURAT has released guidelines on practical aspects of sequencing completely the human genome in a medical context.