Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02428101
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-28
First Post:
2015-04-23
Brief Title:
Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Relation of Genetic Polymorphism of ABCG2 Gene And Occurrence of Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AA -rs3114018 genotypes and correlated with peripheral neuropathy grades
The DNA will be extracted from patients blood samples and are analyzed for the ABCG2 single nucleotide polymorphism G34A - rs2231137 and AA -rs3114018 genotypes and correlated with peripheral neuropathy grades
Detailed Description:
Pharmacogenetic analysisgenotyping
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 AA - rs3114018
Forward
5- TGATGTTCCTTCAGCCACTG-3
Reverse
5-TTGTGGAAACCTCACAAAAGTG-3
- Annealing temp 59 - Product size 124
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 AA - rs3114018
Forward
5- TGATGTTCCTTCAGCCACTG-3
Reverse
5-TTGTGGAAACCTCACAAAAGTG-3
- Annealing temp 59 - Product size 124
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None