Investigation of Cisplatin-Related Kidney Toxicity

This study is currently recruiting participants.

Verified August 2012 by University of Chicago

Sponsor:

Collaborators:

American Society of Clinical Oncology

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Peter O' Donnell, University of Chicago

ClinicalTrials.gov Identifier:

NCT00984035

First received: September 22, 2009

Last updated: August 13, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 22, 2009

Last Updated Date

August 13, 2012

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in urine biomarker (NGAL) after cisplatin [ Time Frame: while on drug and up to 35 days after end of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00984035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in blood and urine cystatin C [ Time Frame: while on drug and up to 35 days after end of treatment ] [ Designated as safety issue: No ]
Change in blood NGAL while receiving cisplatin [ Time Frame: while on drug and up to 35 days after end of treatment ] [ Designated as safety issue: No ]
Genetic markers of kidney toxicity [ Time Frame: while on drug and up to 35 days after end of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Investigation of Cisplatin-Related Kidney Toxicity

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Urine Blood Serum/Plasma Whole Blood

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.

Condition ^ICMJE

Cancer

Intervention ^ICMJE

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.

Study Group/Cohort (s)

Prospecitive Analysis
Patients currently receiving cisplatin as treatment for their cancer.
Interventions:
- Other: urine samples (biomarkers)
- Other: blood samples (biomarkers)
- Other: blood sample (DNA)
Restrospective Analysis
Patients that have previously received cisplatin as treatment for their cancer.

Intervention: Other: blood sample (DNA)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

341

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00984035

Other Study ID Numbers ^ICMJE

09-135-B

Has Data Monitoring Committee

Responsible Party

Peter O' Donnell, University of Chicago

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Peter H O'Donnell, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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