Investigation of Cisplatin-Related Kidney Toxicity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Society of Clinical Oncology
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00984035
First received: September 22, 2009
Last updated: March 3, 2014
Last verified: March 2014

September 22, 2009
March 3, 2014
September 2009
July 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00984035 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Investigation of Cisplatin-Related Kidney Toxicity
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Urine Blood Serum/Plasma Whole Blood

Non-Probability Sample

Patients receiving anti-cancer treatment with cisplatin (or previously treated with cisplatin) at a participating academic medical center.

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.
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
341
July 2016
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984035
09-135-B
No
University of Chicago
University of Chicago
  • American Society of Clinical Oncology
  • National Institutes of Health (NIH)
Principal Investigator: Peter H O'Donnell, MD University of Chicago
University of Chicago
March 2014

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