Clinical trial · Observational
The Enzymatic Activity of Lymphocyte Dihydropyrimidine Dehydrogenase DPD in the Blood as a Predictive and Prognostic Factor in Patients With Digestive Cancer in the First or Second Metastatic Line
NCT03205735CI-TRIAL-00052526DPD DIGunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An observational study of a prospective, analytical, monocentric cohort which does not modify the patient care because the phenotyping of the dihydropyrimidine déshydrogénase DPD (lymphocyte activity) is already carried out in routine hospital. The analysis will be based on clinical, radiological and biological criteria.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic or Locally-advanced Digestive Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymphocyte DPD dosage | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- normal DPD result group
- description
- patients group with a normal DPD result
- interventionNames
- Diagnostic Test: lymphocyte DPD dosage
- label
- elevated DPD result group
- description
- patients group with an elevated DPD result
- interventionNames
- Diagnostic Test: lymphocyte DPD dosage
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- june 2019
- description
- progression free survival calculated between diagnosis date and progression date or death date
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be \> or = to 18 of age on day of signing informed consent * ECOG 0 to 2, * Patient with digestive cancer, all histologic type, * Patient who will receive a metastatic or locally-advanced first or second line treatment by 5-FU or capecitabine, * Patient with measurable lesions based on RECIST 1.1 criteria, * Be willing and able to provide written informed consent/assent for the trial, * Health care insurance available Exclusion Criteria: * Be \< to 18 of age on day of signing informed consent, * Patient without measurable lesion based on RECIST 1.1 criteria, * ECOG \> 2, * Patients refusing to participate in the study or unable to give an oral consent, * Contraindication of 5-FU or capecitabine treatment, * People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside state to express their consent, pregnant or breastfeeding women.
References
Publications (0)
Data not yet available
No reference posted for this study.