Overview

This trial is active, not recruiting.

Condition cancer
Treatments urine samples (biomarkers), blood samples (biomarkers), blood sample (dna)
Sponsor University of Chicago
Collaborator American Society of Clinical Oncology
Start date September 2009
End date July 2016
Trial size 341 participants
Trial identifier NCT00984035, 09-135-B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients currently receiving cisplatin as treatment for their cancer.
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.
Patients that have previously received cisplatin as treatment for their cancer.
blood sample (dna)
Blood sample collected for DNA analysis at anytime while on-study.

Primary Outcomes

Measure
Change in urine biomarker (NGAL) after cisplatin
time frame: while on drug and up to 35 days after end of treatment

Secondary Outcomes

Measure
Change in blood and urine cystatin C
time frame: while on drug and up to 35 days after end of treatment
Change in blood NGAL while receiving cisplatin
time frame: while on drug and up to 35 days after end of treatment
Genetic markers of kidney toxicity
time frame: while on drug and up to 35 days after end of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity
Principal investigator Peter H O'Donnell, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Chicago.