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

University of Chicago1 site in 1 country102 target enrollmentSeptember 22, 2009

ConditionsCancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: University of Chicago
Enrollment: 102
Locations: 1
Primary Endpoint: Change in urine biomarker (NGAL) after cisplatin
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 22, 2009

End Date

March 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

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.

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)