Investigation of Cisplatin-Related Kidney Toxicity

Study Overview
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Brief Summary
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The purpose of this study is to identify novel biomarkers of kidney injury in patients receiving cisplatin. This study will also collect DNA for future analysis.

Detailed Description
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This study will look for novel biomarkers of kidney injury in patients receiving cisplatin in patients currently receiving cisplatin. DNA will be collected both prospectively and retrospectively (from patients that have previously received cisplatin.

Official Title
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Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity

Conditions
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Cancer

Intervention / Treatment
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* Other: urine samples (biomarkers)
* Other: blood samples (biomarkers)
* Other: blood sample (DNA)


Participation Criteria
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Eligibility Criteria
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Prospective Analysis Group Inclusion Criteria: Patients about to receive intravenous cisplatin for the first time as part of cancer chemotherapy. Aged 18 years and older. Ability to understand and willingness to sign a written consent document. Patients may be receiving cisplatin in combination with other chemotherapeutic agents. Patients may be receiving cisplatin in the context of another clinical trial. Exclusion Criteria: Prior receipt of cisplatin. Patients on dialysis or other renal replacement therapy prior to starting cisplatin. Uncontrolled hypo- or hyperthyroidism (patients on chronic stable doses of thyroid replacement medication are eligible). Retrospective Analysis Group Inclusion Criteria: Patients that have previously received intravenous cisplatin as part of cancer chemotherapy. Aged 18 years and older. Ability to understand and willingness to sign a written consent document. Patients that received cisplatin in combination with other chemotherapeutic agents are eligible. Patients that received cisplatin in the context of a clinical trial are eligible. Exclusion Criteria: Unable or unwilling to submit to a one-time blood draw.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospecitive Analysis<br>Patients currently receiving cisplatin as treatment for their cancer. | Other: urine samples (biomarkers)<br>* Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.<br>Other: blood samples (biomarkers)<br>* blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.<br>Other: blood sample (DNA)<br>* Blood sample collected for DNA analysis at anytime while on-study.<br>|
| Restrospective Analysis<br>Patients that have previously received cisplatin as treatment for their cancer. | Other: blood sample (DNA)<br>* Blood sample collected for DNA analysis at anytime while on-study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine biomarker (NGAL) after cisplatin |  | while on drug and up to 35 days after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood and urine cystatin C |  | while on drug and up to 35 days after end of treatment | 
| Change in blood NGAL while receiving cisplatin |  | while on drug and up to 35 days after end of treatment | 
| Genetic markers of kidney toxicity |  | while on drug and up to 35 days after end of treatment |