Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer

• Conditions: Gastrointestinal Tract Cancer; Peripheral Neuropathy

• Registration Number: NCT02428101
• Lead Sponsor: Ain Shams University

Brief 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.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-02
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Abbasia, Egypt