Clinical trial · Observational
Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients
NCT06765252CI-TRIAL-00084514recruitingClinicalTrials.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)
The goal of this observational study is to study the effect of a single nucleotide polymorphism in the CES1 gene (rs2244613) on capecitabine-induced toxicity in Egyptian cancer patients. This study will help in understanding the interindividual variability in the CES1 gene and the effect of a single nucleotide polymorphism in this gene (rs2244613) on capecitabine-induced toxicity in participants already taking capecitabine-based chemotherapy as part of their regular medical care.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine-based chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Occurrence of gastrointestinal toxicity
- timeFrame
- Six months
- description
- Occurrence and severity of capecitabine-induced gastrointestinal toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE V5.0) in relation to the variation in patients' genotype of rs2244613 in the CES1 gene.
- measure
- Occurrence of hand-foot syndrome
- timeFrame
- Six months
- description
- Occurrence and severity of capecitabine-induced Hand-foot syndrome will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE V5.0) in relation to the variation in patients' genotype of rs2244613 in the CES1 gene.
Secondary outcomes (2)
- measure
- Occurrence of hematological toxicity
- timeFrame
- Six months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy * Age \> 18 years * ECOG PS 0-2. Exclusion Criteria: * Patients treated with irinotecan * Lack of physical integrity of the upper gastrointestinal tract * Patients with malabsorption syndrome * Patients having inability to take oral medication * Patients with poor performance status * Patients with chronic diarrhea as ulcerative colitis or Crohn's disease
References
Publications (0)
Data not yet available
No reference posted for this study.