Investigation of Cisplatin-Related Kidney Toxicity

The University of Chicago

Status: Completed

Conditions: Cancer

Treatments: Other: urine samples (biomarkers); Other: blood sample (DNA); Other: blood samples (biomarkers)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00984035

09-135-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

102 participants in 2 patient groups

Prospecitive Analysis

Description:

Patients currently receiving cisplatin as treatment for their cancer.

Treatment:

Other: blood samples (biomarkers)

Other: blood sample (DNA)

Other: urine samples (biomarkers)

Restrospective Analysis

Description:

Patients that have previously received cisplatin as treatment for their cancer.

Treatment:

Other: blood sample (DNA)