Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer

Peripheral Neuropathy Clinical Trial

Official title:

Relation of Genetic Polymorphism of ABCG2 Gene And Occurrence of Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02428101
• Other study ID #: master(No.38)
• Status: Enrolling by invitation
• Start date: November 2014
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Neoplasms
• Gastrointestinal Tract Cancer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Genetic:
• polymorphism analysis

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 6 cycles of chemotherapy (each cycle is15 days), for six months