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Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer

NCT ID: NCT02428101

Last Updated: 2023-11-28

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

ENROLLING_BY_INVITATION

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2024-04-30

Brief Summary

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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

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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

Conditions

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Gastrointestinal Tract Cancer Peripheral Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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polymorphism analysis

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Gastrointestinal Tract Cancer patients treated with Oxaliplatin-containing chemotherapy
* Measurable disease
* Age of 18 years to 80 years

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Inas M Ahmed, PH

African Union,organization St. Abbsia, Cairo, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inas M Moukhtar Ahmed, B.pharma

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy, Ain Shams Universty

Lamia M El Wakeel, Assoc. Prof

Role: STUDY_DIRECTOR

Clinical Pharmacy, Ain Shams University

Abdel Hady A Abdel Wahab, Professor

Role: STUDY_CHAIR

Biochemistry & Molecular biology,Cairo University

Amr S Saad, Assoc. Prof

Role: STUDY_CHAIR

Clinical Oncology, Ain Shams University

Raafat R Abdel-Malek, Assoc. Prof

Role: STUDY_CHAIR

clinical oncology, cairo university

Locations

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Ain Shams University hospitals

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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master(No.38)

Identifier Type: -

Identifier Source: org_study_id