Colorectal CancerNCT06765252
Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients
An observational study of Colorectal Cancer and Breast Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Breast Cancer
- What is being tested?
- Capecitabine-based chemotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Egyptian cancer patients presenting to the department of Clinical Oncology, Faculty of Medicine, Menoufia University.
Who may be able to join
- Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy
- Age > 18 years
- ECOG PS 0-2.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology, Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, 32511
About this study
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
- Colorectal Cancer, Breast Cancer
- Being tested
- Capecitabine-based chemotherapy
- Keywords
- Polymorphism, CES1, Capecitabine, Toxicity, Cancer
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine-based chemotherapyDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Six months
Secondary outcomes (2)
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.
Measured: Six months
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Apr 2024
- Primary completionApr 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Raghad Essam Nassar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765252
- Sponsor's protocol ID
- 4/2024ONCO16
- Other IDs
- 281
- Status last verified
- Jan 2025
- First submitted
- 12 Nov 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients
- ClinicalTrials.gov ID
- NCT06765252
- Acronym / sponsor ID
- 4/2024ONCO16
- Conditions
- Colorectal Cancer, Breast Cancer
- Keywords
- Polymorphism, CES1, Capecitabine, Toxicity, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian cancer patients presenting to the department of Clinical Oncology, Faculty of Medicine, Menoufia University.
Key inclusion criteria (3 listed)
- Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy
- Age > 18 years
- ECOG PS 0-2.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine-based chemotherapyParticipants 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. | Drug | – |
Primary outcome
Occurrence of gastrointestinal toxicity
Time frame: Six months
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.
Occurrence of hand-foot syndrome
Time frame: Six months
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.
2 secondary outcomes
Occurrence of hematological toxicity
Time frame: Six months
Occurrence of hepatic toxicity
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Breast Cancer, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raghad Nassar, Teaching Assistant (01004446077 ext. 002, raghad.essam22@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of gastrointestinal toxicity (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.