NCT01936376

A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Foundation for the National Institutes of Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

Detailed description

The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

Conditions

• Head and Neck Cancer

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-09-06
• Last updated: 2015-01-27

Locations

3 sites across 1 country: United States