Skip to main content
OpenTrials
Completed

NCT Number: NCT00984035

Investigation of Cisplatin-Related Kidney Toxicity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

urine samples (biomarkers)

Other

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)

Other

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)

Other

Blood sample collected for DNA analysis at anytime while on-study.

Primary outcomes

  1. Change in urine biomarker (NGAL) after cisplatin

    Time frame: while on drug and up to 35 days after end of treatment

Secondary outcomes

  1. Change in blood and urine cystatin C

    Time frame: while on drug and up to 35 days after end of treatment

  2. Change in blood NGAL while receiving cisplatin

    Time frame: while on drug and up to 35 days after end of treatment

  3. Genetic markers of kidney toxicity

    Time frame: while on drug and up to 35 days after end of treatment

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • American Society of Clinical Oncology
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Sep 24, 2009
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.