A gene is a code present in each cell of your body and it controls the life of that cell. Each cell in the human body contains about 25,000 to 35,000 genes. Genes carry the information that determines your “traits”, which are characteristics that you inherit from your parents. Genes determine who you are and what you look like, for instance, your physical characteristics (phenotype). Genes can change and this change is called a mutation.
Precision medicine is a medical approach that uses information about a person's genes, their mutations and other biological data (such as biomarkers) as well as lifestyle habits for the purpose of preventing, diagnosing or treating a disease.
Medical practice is based on preventive, diagnostic and therapeutic interventions, whose efficacy (benefits) and safety (absence of unwanted effects) must be proven through rigorous medical research.
While pre-clinical research is medical research carried out in a laboratory, without direct patient involvement and is aimed at collecting preliminary safety and efficacy data, clinical research involves people in so called “clinical studies” and is aimed at evaluating efficacy and safety of therapeutic interventions in the clinical setting.
“Basket Trials” are a new type of clinical studies focused on the treatment of
cancer patients carrying a specific mutation, but for which cancer location or type may be different.
In order to decide whether to take part in a clinical trial, a person should receive all the information regarding the trial by the doctor and should be given enough time to ask questions and think about the proposal. In order to express the consent to participate in the trial, the person must sign an informed consent form.
