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Status unknownNCT01936376Updated Jan 27, 2015

A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

An observational study in Head and Neck Cancer, sponsored by Foundation for the National Institutes of Health. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Foundation for the National Institutes of Health · Observational

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

Read the detailed description

The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • kidney safety
  • biomarkers
  • serum creatinine
  • BUN
  • cystic fibrosis
  • head and neck cancer
  • renal injury
  • drug induced acute kidney injury
  • aminoglycoside
  • cisplatin
  • nephrotoxicity
  • biomarker qualification
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Foundation for the National Institutes of Health is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

cancer patients

Eligibility criteria

Inclusion Criteria (Cisplatin Treatment Group):

  1. Males and females ≥ 18 years of age

  2. Diagnosis of head \& neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:

    • as single agent chemotherapy in conjunction with local radiotherapy course, or
    • as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)
  3. Willingness and ability to comply with study procedures and study restrictions
  4. Ability to provide written informed consent

Inclusion Criteria (Control Group):

  1. Males and females ≥ 18 years of age
  2. Diagnosis of head \& neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)
  3. Willingness and ability to comply with study procedures and study restrictions
  4. Ability to provide written informed consent

Exclusion Criteria (All Subjects):

  1. Chronic kidney disease defined by eGFR \<60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (>30 mcg/mg creatinine) will be excluded
  2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
  3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month
  4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
  5. Use of creatine supplements within 7 days prior to hospitalization
  6. Solid organ transplant recipients
  7. Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)
  8. Significant anemia (Hemoglobin \< 10 g/dL)
  9. Pregnancy
  10. Institutionalized individuals
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • head & neck cancer patients, cisplatin treatment
  • cancer patients, no cisplatin, no nephrotoxic agent
06

What researchers measure

Primary outcomes

  1. biomarker change from baseline

    Time frame: up to 3 weeks

07

Study locations

2 of 3 sites recruiting
  • Harvard Medical School - Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
    • Research Coordinator1 · Contact
    • Research Coordinator2 · Contact
    • Sushrut Waikar, MD · Principal investigator
    Not yet recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    • Research Coordinator1 · Contact
    • Research Coordinator2 · Contact
    • Robert Haddad, MD · Principal investigator
    Recruiting
  • University of Texas MD Anderson
    Houston, Texas 77030, United States
    • Research Coordinator1 · Contact
    • Research Coordinator2 · Contact
    • Bonnie Glisson, MD · Principal investigator
    • Ala Abudayyeh, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01936376
Lead sponsor
Foundation for the National Institutes of Health
Collaborators
University of Southern California, University of Minnesota, M.D. Anderson Cancer Center, Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Amgen, AstraZeneca, Eli Lilly and Company, Johnson & Johnson, Merck Sharp & Dohme LLC, Pfizer, Critical Path Institute - Predictive Safety Testing Consortium
Responsible party
Sponsor
First posted
Sep 6, 2013
Start date
Sep 2012
Primary completion
Jun 2015 (estimated)
Completion
Jun 2015 (estimated)
Last update
Jan 27, 2015

Study contacts

Stefan Sultana, MD
Contact
stefan.sultana@novartis.com
Jessica Ratay, MS
Contact
jratay@fnih.org
(301) 435-4038
Abdulla Salahudeen, MD
principal investigator · University of Texas MD Anderson
Sushrut Waikar, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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