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
  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: July 2016
Estimated Primary Completion Date: July 2015 (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984035

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
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: 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: March 3, 2014
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 July 20, 2014