Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients

NCT ID: NCT06765252

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Capecitabine-based chemotherapy

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Raghad Essam Nassar

Teaching Assistant, Clinical Pharmacy Department, Faculty of Pharmacy, Menoufia University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Oncology, Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Raghad Nassar, Teaching Assistant

Role: CONTACT

01004446077 ext. 002

Other Identifiers

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281

Identifier Type: OTHER

Identifier Source: secondary_id

4/2024ONCO16

Identifier Type: -

Identifier Source: org_study_id

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