Clinical trial · Observational
A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
NCT01936376CI-TRIAL-00016712unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- head & neck cancer patients, cisplatin treatment
- label
- cancer patients, no cisplatin, no nephrotoxic agent
Primary outcomes (1)
- measure
- biomarker change from baseline
- timeFrame
- up to 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (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 Inclusion Criteria (Control Group): 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 (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
References
Publications (0)
Data not yet available
No reference posted for this study.