Clinical trial NCT02428101: Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
Official title: Relation of Genetic Polymorphism of ABCG2 Gene And Occurrence of Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastrointestinal Tract Cancer
Peripheral Neuropathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Gastrointestinal tract (GIT) Cancer

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

Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: After 6 cycles of chemotherapy (each cycle is15 days), for six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
state: Abbasia
Study officials:
affiliation: Faculty of Pharmacy, Ain Shams Universty
name: Inas M Moukhtar Ahmed, B.pharma
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Pharmacy, Ain Shams University
name: Lamia M El Wakeel, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Biochemistry & Molecular biology,Cairo University
name: Abdel Hady A Abdel Wahab, Professor
role: STUDY_CHAIR
affiliation: Clinical Oncology, Ain Shams University
name: Amr S Saad, Assoc. Prof
role: STUDY_CHAIR
affiliation: clinical oncology, cairo university
name: Raafat R Abdel-Malek, Assoc. Prof
role: STUDY_CHAIR
References: