Investigation of Cisplatin-Related Kidney Toxicity
This study is currently recruiting participants.
Verified August 2012 by University of Chicago
Sponsor:
University of Chicago
Collaborators:
American Society of Clinical Oncology
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Other: urine samples (biomarkers) Other: blood samples (biomarkers) Other: blood sample (DNA) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
Biospecimen Retention: Samples With DNA
Urine Blood Serum/Plasma Whole Blood
| Estimated Enrollment: | 341 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984035
Locations
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Peter H O'Donnell, MD 773-702-4400 podonnel@medicine.bsd.uchicago.edu | |
| Principal Investigator: Peter H O'Donnell, MD | |
Sponsors and Collaborators
University of Chicago
American Society of Clinical Oncology
Investigators
| Principal Investigator: | Peter H O'Donnell, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Peter O' Donnell, Instructor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00984035 History of Changes |
| Other Study ID Numbers: | 09-135-B |
| Study First Received: | September 22, 2009 |
| Last Updated: | August 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cisplatin Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013