Investigation of Cisplatin-Related Kidney Toxicity

NCT00984035 | Completed

• 1 other identifier: 09-135-B
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Change in urine biomarker (NGAL) after cisplatin

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

Secondary Outcomes (3)

• Change in blood and urine cystatin C

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

• Change in blood NGAL while receiving cisplatin

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

• Genetic markers of kidney toxicity

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

Study Arms (2)

Prospecitive Analysis

Patients currently receiving cisplatin as treatment for their cancer.

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.

Other: blood sample (DNA)

Interventions

urine samples (biomarkers) OTHER

Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.

Prospecitive Analysis

blood samples (biomarkers) OTHER

blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.

Prospecitive Analysis

blood sample (DNA) OTHER

Blood sample collected for DNA analysis at anytime while on-study.

Prospecitive Analysis; Restrospective Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Unable or unwilling to submit to a one-time blood draw.

Sponsors & Collaborators

• University of Chicago: lead
• American Society of Clinical Oncology: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine Blood Serum/Plasma Whole Blood

MeSH Terms

Conditions

Neoplasms

Interventions

Biomarkers; Blood Specimen Collection; DNA

Intervention Hierarchy (Ancestors)

Biological Factors; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Peter H O'Donnell, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: September 22, 2009
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (1)