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Brief Title: Pre-therapeutic Identification of Dihydropyrimidine Dehydrogenase Gene (DPD) Deficiency for Predicting Toxicity to Fluoropyrimidines
Official Title: The Medical-financial Evaluation of Pre-therapeutic Screening by a Joint Phenotypic-pharmacogenetic Approach for Metabolic Fluoropyrimidine Enzyme Deficiency in Terms of Serious Toxicity Risk Prevention : a Multicentric Case Study
Study ID: NCT01547923
Brief Summary: The aim of this study is to demonstrate the medical and financial benefit of pre-therapeutic screening of DPD deficiency for predicting toxicity to fluoropyrimidines.
Detailed Description: The fluoropyrimidines, of which 5-Fluorouracil is the most important, represent a family of medication that is used in particular in cancerology. They are molecules widely used in cancerology since they can be found in nearly 45% of chemotherapy protocols and in the treatment of about 50% of cancers (colorectum, oesophagus, stomach, breast, upper digestive and respiratory tracts). They are not only used in metastatic situations but also more and more in adjuvant situations, in other words for patients treated for a localised tumour, presenting a risk of relapse. A severe toxic risk cannot be tolerated in these conditions, and the doctor should assure the maximum level of safety for his patients. These medicines are the cause of 3% of grade IV toxicity from the first or second administration, and for 0.3% of deaths. To this one can add on a total of 20 to 25% grade III-IV toxic events. Anticancer treatment is mostly administered by body size and in the best of cases after a few basic biological examinations such as a haemogram and renal status, without taking into consideration any individual particularities, whether genetic or epigenetic. Among potential toxicity risk factors one can find individual metabolic differences linked to genetic modifications of metabolism enzymes as well as differences in the chemical receptors and transporters. For fluoropyrimidines, a polymorphism was found for the dihydropyrimidine dehydrogenase gene (DPD), a major catabolism enzyme. A deficit of this enzyme is a major counter-indication for the use of these medicines. Early determination of DPD status would allow identification of patients at risk and would thus help in subsequent dose adjustment or selection of other treatment modalities.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
ICO Paul Papin, Angers, , France
CHU Jean Minjoz, Besançon, , France
CHU Morvan, Brest, , France
CHU Côte de Nacre, Caen, , France
Centre François Baclesse, Caen, , France
Pôle Santé Léonard de Vinci, Chambray-les-Tours, , France
Centre Hospitalier du Haut Anjou, Chateau-Gontier, , France
Centre Hospitalier, Cholet, , France
Clinique des Cèdres, Cornebarrieu, , France
Hôpital Henri Mondor, Créteil, , France
CH Sarthe et Loir, La Flèche, , France
Centre Hospitalier Les oudairies, La Roche Sur Yon, , France
Centre Hospitalier, Laval, , France
Centre Hospitalier, Le Mans, , France
Centre Oscar Lambret, Lille, , France
Centre d'oncologie de Gentilly, Nancy, , France
CHU Hotel Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
HEGP, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Bénite, , France
Centre Hospitalier, Saumur, , France
ICO René Gauducheau, St Herblain, , France
Institut Claudius Regaud, Toulouse, , France
Hôpital Purpan, Toulouse, , France
CHU Trousseau, Tours, , France
Name: Olivier Capitain, MD, PhD
Affiliation: Institut Cancerologie de l'Ouest
Role: PRINCIPAL_INVESTIGATOR