Status:
UNKNOWN
Evaluation of the Effect of Genetic Polymorphisms in ERCC1 and OCT2 on the Occurrence and Severity of Cisplatin-induced Nephrotoxicity
Lead Sponsor:
Ain Shams University
Conditions:
Cisplatin Adverse Reaction
Eligibility:
All Genders
18+ years
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 pharmacoki...
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 pharmacoki...
Eligibility Criteria
Inclusion
- Males or females aged \>18 years receiving cisplatin-containing chemotherapy.
- A Cisplatin dose starting from 75 mg/m2
- Various cancer types
- No history of organ transplantation or kidney dialysis.
- Patients with normal renal function
Exclusion
- Co-administration of ifosfamide with cisplatin, because of the known risk of nephrotoxicity.
- Pregnant or lactation.
- Infection with the human immunodeficiency virus (HIV).
- Prior administration of cisplatin.
- Intraperitoneal chemotherapy.
- Inadequate liver function (bilirubin \> 1.5 times upper normal limit (UNL) and alanine transaminase (ALT) or aspartate transaminase (AST) \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
- Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50 mL/min).
- Serious comorbid systemic disorder incompatible with the study (uncontrolled diabetes mellitus (DM) or hypertension (HTN), myocardial infarction within the last 6 months).
- Patients diagnosed with kidney cancer.
- Exposure to any nephrotoxic drugs or agents.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05247671
Start Date
February 15 2022
End Date
December 15 2022
Last Update
February 21 2022
Active Locations (1)
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1
Faculty of medicine, Ain Shams University
Cairo, Egypt