Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05247671
Status:
UNKNOWN
Last Update Posted:
2022-02-21
First Post:
2021-12-10
Brief Title:
Evaluation of the Effect of Genetic Polymorphisms in ERCC1 and OCT2 on the Occurrence and Severity of Cisplatin-induced Nephrotoxicity
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Evaluation of the Effect of Genetic Polymorphisms in ERCC1 and OCT2 on the Occurrence and Severity of Cisplatin-induced Nephrotoxicity
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
NOT_YET_RECRUITING
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:
Approximately one-third of all patients treated with cisplatin develop renal dysfunction after a single dosage of cisplatin Germline genetic polymorphisms may cause variations in cisplatin pharmacokinetics and in the ability of epithelial kidney cells to take up cisplatin and repair cisplatin-induced Deoxyribonucleic Acid DNA damage Knowledge concerning which genotypes are associated with cisplatin-induced nephrotoxicity may help to identify at-risk patients and initiate strategies such as using lower or fractionated cisplatin doses or avoiding cisplatin altogether to prevent Acute Kidney Injury AKI
Detailed Description:
Approximately one-third of all patients treated with cisplatin develop renal dysfunction after a single dosage of cisplatin Germline genetic polymorphisms may cause variations in cisplatin pharmacokinetics and in the ability of epithelial kidney cells to take up cisplatin and repair cisplatin-induced DNA damage Knowledge concerning which genotypes are associated with cisplatin-induced nephrotoxicity may help to identify at-risk patients and initiate strategies such as using lower or fractionated cisplatin doses or avoiding cisplatin altogether to prevent AKI
Patient written informed consent will be taken prior to study conductance
1 Full laboratory evaluation before and after cisplatin administration including
Complete Blood Count CBC liver and renal functions glomerular filtration rate GFR and estimated glomerular filtration rate eGFR Serum electrolytes Marker of nephrotoxicity Cystatin C
2 Sample Collection and single nucleotide polymorphism SNP Genotyping
Venous blood 2 mL will be collected from each subject into tubes containing 50 mmol of Ethylenediamine tetraacetic acid EDTA per liter and genomic DNA will be isolated with the GeneJET Whole Blood Genomic DNA purification Mini kit according to manufacturers instructions Polymorphisms will be assessed using the TaqMan based real-time polymerase chain reaction PCR assay
This study aims to assess the influence of single nucleotide polymorphisms in the DNA repair gene Excision Repair Cross Complementation group 1 ERCC1 and Cisplatin uptake transporter gene Organic Cation Transporter 2 OCT2 on cisplatin-induced nephrotoxicity by assessment of the following
1 Occurrence of nephrotoxicity
2 Degree of renal impairment
3 Changes in traditional and novel protein biomarkers for AKI
Patient written informed consent will be taken prior to study conductance
1 Full laboratory evaluation before and after cisplatin administration including
Complete Blood Count CBC liver and renal functions glomerular filtration rate GFR and estimated glomerular filtration rate eGFR Serum electrolytes Marker of nephrotoxicity Cystatin C
2 Sample Collection and single nucleotide polymorphism SNP Genotyping
Venous blood 2 mL will be collected from each subject into tubes containing 50 mmol of Ethylenediamine tetraacetic acid EDTA per liter and genomic DNA will be isolated with the GeneJET Whole Blood Genomic DNA purification Mini kit according to manufacturers instructions Polymorphisms will be assessed using the TaqMan based real-time polymerase chain reaction PCR assay
This study aims to assess the influence of single nucleotide polymorphisms in the DNA repair gene Excision Repair Cross Complementation group 1 ERCC1 and Cisplatin uptake transporter gene Organic Cation Transporter 2 OCT2 on cisplatin-induced nephrotoxicity by assessment of the following
1 Occurrence of nephrotoxicity
2 Degree of renal impairment
3 Changes in traditional and novel protein biomarkers for AKI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None