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
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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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 |
|---|---|
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Prospecitive Analysis
Patients currently receiving cisplatin as treatment for their cancer.
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Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
Blood sample collected for DNA analysis at anytime while on-study.
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Restrospective Analysis
Patients that have previously received cisplatin as treatment for their cancer.
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Blood sample collected for DNA analysis at anytime while on-study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change in urine biomarker (NGAL) after cisplatin
Time Frame: while on drug and up to 35 days after end of treatment
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while on drug and up to 35 days after end of treatment
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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
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while on drug and up to 35 days after end of treatment
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Change in blood NGAL while receiving cisplatin
Time Frame: while on drug and up to 35 days after end of treatment
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while on drug and up to 35 days after end of treatment
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Genetic markers of kidney toxicity
Time Frame: while on drug and up to 35 days after end of treatment
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while on drug and up to 35 days after end of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.