Investigation of Cisplatin-Related Kidney Toxicity

September 10, 2018 updated by: University of Chicago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospecitive Analysis
Patients currently receiving cisplatin as treatment for their cancer.
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.
Other: 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.
Other: blood sample (DNA)
Blood sample collected for DNA analysis at anytime while on-study.
Restrospective Analysis
Patients that have previously received cisplatin as treatment for their cancer.
Other: blood sample (DNA)
Blood sample collected for DNA analysis at anytime while on-study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in blood and urine cystatin C
Time Frame: while on drug and up to 35 days after end of treatment
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
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
while on drug and up to 35 days after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

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

Investigators

  • Principal Investigator: Peter H O'Donnell, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2009

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 09-135-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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