Gastrointestinal Tract CancerNCT02428101
Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
An observational study of Gastrointestinal Tract Cancer and Peripheral Neuropathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study will examine DNA from Gastrointestinal Tract of cancer patients treated with oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to drug-induced peripheral neuropathy in certain patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Tract Cancer, Peripheral Neuropathy
- What is being tested?
- polymorphism analysis
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2014to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Gastrointestinal tract (GIT) Cancer
Who may be able to join
- Gastrointestinal Tract Cancer patients treated with Oxaliplatin-containing chemotherapy
- Measurable disease
- Age of 18 years to 80 years
Who cannot join
- Pregnant women
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oxaliplatin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Neurologic disease or patients with disease impairing the neurologic function affecting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation of Genetic Polymorphism of ABCG2 Gene And Occurrence of Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
This study will examine DNA from Gastrointestinal Tract of cancer patients treated with oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to drug-induced peripheral neuropathy in certain patients.
The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2 single nucleotide polymorphism (G34A - rs2231137 and A/A -rs3114018 genotypes) and correlated with peripheral neuropathy grades.
Read the detailed description
Pharmacogenetic analysis/genotyping :
Genotyping is conducted via High Resolution Melting (HRM) TECHNIQUE, To confirm the genotyping results, the Polymerase chain reaction (PCR) product of the samples will be examine via direct sequencing using 3500 Genetic analyzer from ThermoFisher (applied biosystem) at two ABCG2 loci using the following PCR primers:
1-ABCG2 G34A - rs2231137
Forward :
5'-TGC AAT CTC ATT TAT CTG GAC TA-'3
Reverse :
5'-AAT GCC TTC AGG TCA TTG GA-'3
-Annealing temp :57 -Product size : 163
2- ABCG2 A/A - rs3114018
Forward :
5'- TGATGTTCCTTCAGCCACTG-'3
Reverse :
5'-TTGTGGAAACCTCACAAAAGTG-'3
- Annealing temp : 59 - Product size : 124
- Being tested
- polymorphism analysis
- Medical subject headings
- Gastrointestinal Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymorphism analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of single nucleotide polymorphisms of ABCG2 gene (G34A - rs2231137 and A/A -rs3114018 genotypes) with peripheral neuropathy grades, using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE)
Peripheral Neuropathy Toxicity will be assessed every cycle for six months using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE). Patients will be assigned to 4 groups according to the grades of neuropathy.
Measured: After 6 cycles of chemotherapy (each cycle is15 days), for six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Tract 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
- Responsible party
- Principal investigator, Inas M Ahmed, PH, Ain Shams University
- Investigators
- Inas M Moukhtar Ahmed, B.pharma, Principal investigator, Faculty of Pharmacy, Ain Shams UniverstyLamia M El Wakeel, Assoc. Prof, Study director, Clinical Pharmacy, Ain Shams UniversityAbdel Hady A Abdel Wahab, Professor, Study chair, Biochemistry & Molecular biology,Cairo UniversityAmr S Saad, Assoc. Prof, Study chair, Clinical Oncology, Ain Shams UniversityRaafat R Abdel-Malek, Assoc. Prof, Study chair, clinical oncology, cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428101
- Sponsor's protocol ID
- master(No.38)
- Status last verified
- Nov 2023
- First submitted
- 23 Apr 2015
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Genetic Polymorphism of ABCG2 Gene And Occurrence of Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
- ClinicalTrials.gov ID
- NCT02428101
- Acronym / sponsor ID
- master(No.38)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- 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.
This study will examine DNA from Gastrointestinal Tract of cancer patients treated with oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to drug-induced peripheral neuropathy in certain patients.
The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2 single nucleotide polymorphism (G34A - rs2231137 and A/A -rs3114018 genotypes) and correlated with peripheral neuropathy grades.
Detailed description
Pharmacogenetic analysis/genotyping :
Genotyping is conducted via High Resolution Melting (HRM) TECHNIQUE, To confirm the genotyping results, the Polymerase chain reaction (PCR) product of the samples will be examine via direct sequencing using 3500 Genetic analyzer from ThermoFisher (applied biosystem) at two ABCG2 loci using the following PCR primers:
1-ABCG2 G34A - rs2231137
Forward :
5'-TGC AAT CTC ATT TAT CTG GAC TA-'3
Reverse :
5'-AAT GCC TTC AGG TCA TTG GA-'3
-Annealing temp :57 -Product size : 163
2- ABCG2 A/A - rs3114018
Forward :
5'- TGATGTTCCTTCAGCCACTG-'3
Reverse :
5'-TTGTGGAAACCTCACAAAAGTG-'3
- Annealing temp : 59 - Product size : 124
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Gastrointestinal tract (GIT) Cancer
Key inclusion criteria (3 listed)
- Gastrointestinal Tract Cancer patients treated with Oxaliplatin-containing chemotherapy
- Measurable disease
- Age of 18 years to 80 years
Key exclusion criteria (4 listed)
- Pregnant women
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oxaliplatin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Neurologic disease or patients with disease impairing the neurologic function affecting
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 |
|---|---|---|
| polymorphism analysis | Genetic | – |
Primary outcome
Correlation of single nucleotide polymorphisms of ABCG2 gene (G34A - rs2231137 and A/A -rs3114018 genotypes) with peripheral neuropathy grades, using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE)
Time frame: After 6 cycles of chemotherapy (each cycle is15 days), for six months
Peripheral Neuropathy Toxicity will be assessed every cycle for six months using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE). Patients will be assigned to 4 groups according to the grades of neuropathy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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. This study is not recruiting at the moment.
Inas M Moukhtar Ahmed, B.pharma principal investigator
Faculty of Pharmacy, Ain Shams Universty
Lamia M El Wakeel, Assoc. Prof study director
Clinical Pharmacy, Ain Shams University
Abdel Hady A Abdel Wahab, Professor study chair
Biochemistry & Molecular biology,Cairo University
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 Gastrointestinal Tract Cancer and Peripheral Neuropathy, 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 4 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of single nucleotide polymorphisms of ABCG2 gene (G34A - rs2231137 and A/A -rs3114018 genotypes) with peripheral neuropathy grades, using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) (time frame: After 6 cycles of chemotherapy (each cycle is15 days), for six months). 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 28 Nov 2023.