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| ID | Type | Description | Link |
|---|---|---|---|
| 281 | Other Identifier | Faculty of Pharmacy Ain Shams University |
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| Name | Class |
|---|---|
| Menoufia University | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine-based chemotherapy | Drug | Participants receiving capecitabine in an oral dose of 1,000-1,250 mg/m2 twice daily for the first 14 days of each 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of gastrointestinal toxicity | 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. | Six months |
| Occurrence of hand-foot syndrome | 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. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of hematological toxicity | Occurrence and severity of capecitabine-induced hematological 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. | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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Egyptian cancer patients presenting to the department of Clinical Oncology, Faculty of Medicine, Menoufia University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raghad Nassar, Teaching Assistant | Contact | 01004446077 | 002 | raghad.essam22@pharma.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Faculty of Medicine, Menoufia University | Recruiting | Shibīn al Kawm | Menoufia | 32511 | Egypt |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Occurrence of hepatic toxicity |
Occurrence and severity of capecitabine-induced hyperbilirubinemia 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. |
| Six months |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |