Cancer
Conditions
Brief summary
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
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.
Interventions
OTHERurine samples (biomarkers)
Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
OTHERblood samples (biomarkers)
blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
OTHERblood sample (DNA)
Blood sample collected for DNA analysis at anytime while on-study.
Sponsors
American Society of Clinical Oncology
National Institutes of Health (NIH)
University of Chicago
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urine biomarker (NGAL) after cisplatin | while on drug and up to 35 days after end of treatment |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed