NCT00984035CompletedNot Applicable
Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity
University of Chicago1 site in 1 country102 target enrollmentStarted: September 22, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Change in urine biomarker (NGAL) after cisplatin
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in urine biomarker (NGAL) after cisplatin
Time Frame: while on drug and up to 35 days after end of treatment
Secondary Outcomes
- Genetic markers of kidney toxicity(while on drug and up to 35 days after end of treatment)
- 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)
Investigators
Study Sites (1)
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