Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01547923
Status:
TERMINATED
Last Update Posted:
2020-03-25
First Post:
2012-02-28
Brief Title:
Pre-therapeutic Identification of Dihydropyrimidine Dehydrogenase Gene DPD Deficiency for Predicting Toxicity to Fluoropyrimidines
Sponsor:
Institut Cancerologie de lOuest
Organization:
Institut Cancerologie de lOuest
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study stopped due to a death in the arm control
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPD côlon
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 03 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-000026-39 | EUDRACT_NUMBER | None | None |