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Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Change in urine biomarker (NGAL) after cisplatin

Outcome Time Frame:

while on drug and up to 35 days after end of treatment

Safety Issue:

No

Principal Investigator

Peter H O'Donnell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

09-135-B

NCT ID:

NCT00984035

Start Date:

September 2009

Completion Date:

June 2013

Related Keywords:

  • Cancer

Name

Location

University of ChicagoChicago, Illinois  60637