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Spots Global Cancer Trial Database for Pre-therapeutic Identification of Dihydropyrimidine Dehydrogenase Gene (DPD) Deficiency for Predicting Toxicity to Fluoropyrimidines

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Olivier Capitain, MD, PhD

Affiliation: Institut Cancerologie de l'Ouest

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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