The Phase I Oncological Clinical Trials Unit at the Hospital Clínico Universitario in Valencia was created in 2004 and is pioneering in Spain.This unit develops Phase I Clinical Trials, which are designed to test the efficacy and safety of cancer treatment drugs for the first time in humans.
Cutting-edge clinical trials in oncological research are conducted in the Unit. It actively collaborates with the world’s best hospitals in cancer treatment such as the Massachusetts General Hospital in Boston, the MD Anderson Cancer Center in Houston, the Hospital Vall d’Hebron in Barcelona, and the University of Colorado. Leading pharmaceutical and biotechnology companies such as Millennium in Boston and Genentech, Intellikine in San Francisco, Higlight Therapeutics, as well as pharmaceutical companies as well as Roche, Novartis, AstraZeneca y Janssen, are also involved in these international projects.
One peculiarity of the INCLIVA Research Foundation is that all income generated by the clinical trials is reinvested into research. More than one million euros comes into the unit annually which is entirely devoted to cancer research.
The unit also works on developing research projects in liquid biopsy, to study whether use of liquid biopsies (blood samples) could provide an easy and minimally invasive way to obtain relevant information about presence of tumours in the body, even those undetectable by conventional imaging techniques, and provide information on the molecular mechanisms of resistance to adjuvant chemotherapy treatment.
The innovative approach of this unit, which addresses the diagnosis and treatment of cancer by complete human genome sequencing, enables us to advance in developing less toxic and more specific drugs for each type of cancer and patient; in other words, a move towards personalized medicine.
The second, as well as part of the third, floor at INCLIVA’s headquarters is dedicated to oncological treatments. The Unit also has a specific room for treatments and handling blood samples, with a high-capacity centrifuge and freezer (-40 °C to -86 °C). In addition, it has consultation rooms for patients care and work offices for the nurses, data managers, and for administrative management.
The Phase I Oncological Clinical Trials Unit is directed by Dr. Andrés Cervantes, Head of the Hospital Clínico Universitario Oncology Service, permanent senior lecturer in the Faculty of Medicine at the University of Valencia and director of the INCLIVA Foundation’s line of investigation in Oncology.
Particularly notable among the large number of collaborating researchers in the unit are doctors Desamparados Roda and Valentina Gambardella. The team is also made up of five research nurses, three data managers and three administrative staff, all with extensive experience in clinical trial development, resulting in effective and appropriate care of research participants and development of research excellence.
Desamparados Roda y Valentina Gambardella
Inma Blasco, Celia Martínez, Luna Porta, Verónica García, Cristina Jordá
Data Managers Team
Nacho Castaño, Ana Vercher, Beatriz López
Committed to providing adequate and efficient service to researchers, the Phase I Oncology Trials Unit implemented and certified its quality management system in 2019 in accordance with the requirements of the ISO 9001:2015 standard.