ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of Cisplatin-Related Kidney Toxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00984035
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
American Society of Clinical Oncology
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Chicago

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.


Condition or disease Intervention/treatment
Cancer Other: urine samples (biomarkers) Other: blood samples (biomarkers) Other: blood sample (DNA)

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
Actual Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity
Actual Study Start Date : September 22, 2009
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in urine biomarker (NGAL) after cisplatin [ Time Frame: while on drug and up to 35 days after end of treatment ]

Secondary Outcome Measures :
  1. Change in blood and urine cystatin C [ Time Frame: while on drug and up to 35 days after end of treatment ]
  2. Change in blood NGAL while receiving cisplatin [ Time Frame: while on drug and up to 35 days after end of treatment ]
  3. Genetic markers of kidney toxicity [ Time Frame: while on drug and up to 35 days after end of treatment ]

Biospecimen Retention:   Samples With DNA
Urine Blood Serum/Plasma Whole Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984035


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
American Society of Clinical Oncology
National Institutes of Health (NIH)
Investigators
Principal Investigator: Peter H O'Donnell, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00984035     History of Changes
Other Study ID Numbers: 09-135-B
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents