A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
NCT01936376
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Adult Trials: 18+ Years
(Cisplatin Treatment Group):
1. Males and females ≥ 18 years of age
2. Diagnosis of head & neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:
- as single agent chemotherapy in conjunction with local radiotherapy course, or
- as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)
3. Willingness and ability to comply with study procedures and study restrictions
4. Ability to provide written informed consent
(All Subjects):
1. Chronic kidney disease defined by eGFR <60 mL/min/1.73m2. Patients with normal eGFR
but persistent dipstick proteinuria require urinary albumin measurement: those with
microalbuminuria (>30 mcg/mg creatinine) will be excluded
2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of
high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous
vancomycin, or ACEi)
3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month
4. Patients currently receiving trimethoprim or cimetidine or other medications known to
alter the tubular secretion of creatinine
5. Use of creatine supplements within 7 days prior to hospitalization
6. Solid organ transplant recipients
7. Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)
8. Significant anemia (Hemoglobin < 10 g/dL)
9. Pregnancy
10. Institutionalized individuals
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers | ||||||
| Official Title | A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers | ||||||
| Brief 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. | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples Without DNA Description: urine and blood | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | cancer patients | ||||||
| Condition | Head and Neck Cancer | ||||||
| Intervention | Not Provided | ||||||
| Study Groups/Cohorts |
| ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Unknown status | ||||||
| Estimated Enrollment | 150 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | June 2015 | ||||||
| Estimated Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria (Cisplatin Treatment Group):
Inclusion Criteria (Control Group):
Exclusion Criteria (All Subjects):
| ||||||
| Sex/Gender |
| ||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT01936376 | ||||||
| Other Study ID Numbers | Kidney Safety - Cisplatin | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Foundation for the National Institutes of Health | ||||||
| Study Sponsor | Foundation for the National Institutes of Health | ||||||
| Collaborators |
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| Investigators |
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| PRS Account | Foundation for the National Institutes of Health | ||||||
| Verification Date | July 2014 | ||||||