Inicio Translational Research Working Group (GIT) Prospective translational SEOM

Prospective translational research project to determine predictive factors of efficacy and activity in cancer patients

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This is a prospective study with the objective of identifying and validating predictive biomarkers of efficacy and toxicity of cancer treatments. The secondary objective is to determine biomarkers that are associated with the risk of developing cancer.

For this purpose, biological samples from cancer patients and healthy individuals will be obtained. Such samples include peripheral blood and DNA, as well as urine and other biological samples, including pleural and ascitic fluid, whenever their obtention is necessary from a clinical standpoint. The informed consent also requests authorization from the patients to study their biopsies, with the same objective. The project will be performed in the Oncology Departments that belong to SEOM and its planned duration is 5 years..

Access the study protocol.

This project is compliant with the current legislation for research projects in biological samples. It has been designed in collaboration with legal and ethical experts from the Inter-University Chair in Law and the Human Genome from the Universities of Deusto and the Basque Country and from the Master Program of the Bioethical Department from the University of Navarra, as well as by a legal Bureau specialized in Medical Affairs. The project has been presented and approved by the Ethical Review Boards of several Spanish institutions.

Access the list of approved institutions.

To facilitate the development of the project and the interpretation of results, patients will be agrupated in different subprojects depending on their characteristics. Such subprojects will be coordinated by the clinical investigators based, ideally within the frame of Cancer Cooperative Groups, since one of the main objectives of the project is to foster multicenter research, in order to make possible to obtain large and informative series. The GIT has elaborated an optional template for subprojects.

Access ongoing projects.

The responsible of the samples will be the principal investigator from each institution. The samples will be stored in each institution until their study.  The principal investigator will decide the specific studies that will be performed with the samples, although always within the main objective of the study, as required by the Spanish Legislation, and as approved by the patients and the Ethical Review Boards.

The samples will be obtained sequentially in relevant moments in the history of disease: at baseline (before treatment administration); when response is assessed: and when progression is observed, as well as when any significant event takes place, such as unexpected toxicity.

Samples from healthy individuals will be obtained in other clinical departments that perform the tests that allow to reasonably discard the diagnosis of cancer (e.g: colonoscopy for colorectal cancer).

 

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