Investigation of Cisplatin-Related Kidney Toxicity

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984035
• Other study ID #: 09-135-B
• Status: Completed
• Start date: September 22, 2009
• Est. completion date: March 2018

Study information

• Verified date: September 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• urine samples (biomarkers)
Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
• blood samples (biomarkers)
blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
• blood sample (DNA)
Blood sample collected for DNA analysis at anytime while on-study.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	American Society of Clinical Oncology, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine biomarker (NGAL) after cisplatin		while on drug and up to 35 days after end of treatment
Secondary	Change in blood and urine cystatin C		while on drug and up to 35 days after end of treatment
Secondary	Change in blood NGAL while receiving cisplatin		while on drug and up to 35 days after end of treatment
Secondary	Genetic markers of kidney toxicity		while on drug and up to 35 days after end of treatment