Clinical trial · Interventional
Pre-therapeutic Identification of Dihydropyrimidine Dehydrogenase Gene (DPD) Deficiency for Predicting Toxicity to Fluoropyrimidines
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
NCT01547923CI-TRIAL-00044257DPD côlonterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study stopped due to a death in the arm control
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Intravenous 5 Fluorouracile | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample for phenotypic and pharmacogenetic analysis. | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A : pre-therapeutic screening for DPD deficiency
- description
- Prior to treatment by fluoropyrimidines,a DPD deficiency is identified by a joint phenotypic-pharmacogenetic approach.
- interventionNames
- Genetic: Blood sample for phenotypic and pharmacogenetic analysis.
- type
- OTHER
- label
- B : no pretherapeutic research of DPD deficiency
- description
- For patients included in this arm, a blood sample will be taken prior to treatment by fluoropyrimidines but not analysed. If grade 3 or 4 toxicity levels are encountered during treatment, DPD deficiency will be detected.
- interventionNames
- Genetic: Blood sample for phenotypic and pharmacogenetic analysis.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * colorectal cancer, histologically confirmed, with all types included (including adjuvant cases), requiring treatment with intravenous 5-fluorouracil. * anterior chemotherapy authorised, with the exception of chemotherapy containing a derivate of 5-Fluorouracil * Age \> or = 18 years * WHO Performance status \< or = 2 * Haematologic and hepatic parameters : neutrophils \> or = 1000 /mm3, platelets \> or = 100000/mm3, Total bilirubin \< or = 2 x ULN, AST and ALT \< or = 3 x ULN, APL \< or = 5 x ULN * Complete initial assessment before first treatment administration for imaging and pharmacogenetic, within 15 days for biology, and within 7 days for clinical examination. * Signed written informed consent Exclusion Criteria: * Prior chemotherapy with fluoropyrimidines * Symptomatic or uncontrolled ventral nervous system metastases * Psychiatric Disease disrupting the trial understanding and the enlightened and voluntary consent character * Patient who is pregnant or breast feeding * Woman not consenting to use adequate contraceptive precautions during the study * Patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons * Significant serious pathology or any instable medical condition (cardiac pathology uncontrolled, myocardial infarction within 6 months before enrollment, systemic active uncontrolled infection) * any investigational agent within 4 weeks before enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.