A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
NCT ID: NCT01936376
Last Updated: 2015-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2012-09-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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head & neck cancer patients, cisplatin treatment
No interventions assigned to this group
cancer patients, no cisplatin, no nephrotoxic agent
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
1. Males and females ≥ 18 years of age
2. Diagnosis of head \& neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)
3. Willingness and ability to comply with study procedures and study restrictions
4. Ability to provide written informed consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
University of Minnesota
OTHER
M.D. Anderson Cancer Center
OTHER
Brigham and Women's Hospital
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Eli Lilly and Company
INDUSTRY
Johnson & Johnson
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Pfizer
INDUSTRY
Critical Path Institute - Predictive Safety Testing Consortium
UNKNOWN
Foundation for the National Institutes of Health
OTHER
Responsible Party
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Principal Investigators
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Abdulla Salahudeen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas MD Anderson
Sushrut Waikar, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Texas MD Anderson
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Research Coordinator1
Role: primary
Research Coordinator2
Role: backup
Research Coordinator1
Role: primary
Research Coordinator2
Role: backup
Research Coordinator1
Role: primary
Research Coordinator2
Role: backup
Other Identifiers
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Kidney Safety - Cisplatin
Identifier Type: -
Identifier Source: org_study_id
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