Clinical trial NCT00984035: Investigation of Cisplatin-Related Kidney Toxicity
Official title: Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
name: National Institutes of Health (NIH)
First posted: 2009-09-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving anti-cancer treatment with cisplatin (or previously treated with cisplatin) at a participating academic medical center.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in urine biomarker (NGAL) after cisplatin
timeFrame: while on drug and up to 35 days after end of treatment
Secondary outcomes:
measure: Change in blood and urine cystatin C
timeFrame: while on drug and up to 35 days after end of treatment
measure: Change in blood NGAL while receiving cisplatin
timeFrame: while on drug and up to 35 days after end of treatment
measure: Genetic markers of kidney toxicity
timeFrame: while on drug and up to 35 days after end of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Peter H O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: