Investigation of Cisplatin-Related Kidney Toxicity

NCT ID: NCT00984035

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-22

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospecitive Analysis

Patients currently receiving cisplatin as treatment for their cancer.

urine samples (biomarkers)

Intervention Type 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)

Intervention Type 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)

Intervention Type OTHER

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

Restrospective Analysis

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

blood sample (DNA)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

blood sample (DNA)

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

Intervention Type OTHER

Eligibility Criteria

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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.


* 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

* 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


* Unable or unwilling to submit to a one-time blood draw.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Clinical Oncology

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter H O'Donnell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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09-135-B

Identifier Type: -

Identifier Source: org_study_id

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