Investigation of Cisplatin-Related Kidney Toxicity

Completed

• Conditions: Cancer
• Interventions: Other: urine samples (biomarkers); Other: blood samples (biomarkers); Other: blood sample (DNA)

• Registration Number: NCT00984035
• Lead Sponsor: University of Chicago

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 Timeline

• Study Start: 2009-09-22
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospecitive Analysis	blood sample (DNA)	Patients currently receiving cisplatin as treatment for their cancer.
Prospecitive Analysis	urine samples (biomarkers)	Patients currently receiving cisplatin as treatment for their cancer.
Restrospective Analysis	blood sample (DNA)	Patients that have previously received cisplatin as treatment for their cancer.
Prospecitive Analysis	blood samples (biomarkers)	Patients currently receiving cisplatin as treatment for their cancer.

Primary Outcome Measures

Name	Time	Method
Change in urine biomarker (NGAL) after cisplatin	while on drug and up to 35 days after end of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States