Head and Neck CancerNCT01936376
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 of Head and Neck Cancer, run by Foundation for the National Institutes of Health at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cancer patients
Who may be able to join
- Males and females ≥ 18 years of age
- 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)
- Willingness and ability to comply with study procedures and study restrictions
- Ability to provide written informed consent
Show all 10Show fewer
- Males and females ≥ 18 years of age
- 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)
- Willingness and ability to comply with study procedures and study restrictions
- Ability to provide written informed consent
Who cannot join
- 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
- Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
- Any major surgery (i.e. high risk of acute kidney injury) in the previous month
- Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
- Use of creatine supplements within 7 days prior to hospitalization
- Solid organ transplant recipients
Show all 10Show fewer
- Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)
- Significant anemia (Hemoglobin < 10 g/dL)
- Pregnancy
- Institutionalized individuals
Trial locations and contacts
3 sites in 1 country.
Stefan Sultana, MD contact
United States3 sites, 3 recruiting
- Not yet recruiting
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, 02115
Research Coordinator1
Research Coordinator2
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Research Coordinator1
Research Coordinator2
- Recruiting
University of Texas MD Anderson
Houston, Texas, 77030
Research Coordinator1
Research Coordinator2
About this study
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.
- Conditions
- 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
- Medical subject headings
- Head and Neck Neoplasms, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| head & neck cancer patients, cisplatin treatment | Not described | |
| cancer patients, no cisplatin, no nephrotoxic agent | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarker change from baseline
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for the National Institutes of Health
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Abdulla Salahudeen, MD, Principal investigator, M.D. Anderson Cancer CenterSushrut Waikar, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936376
- Sponsor's protocol ID
- Kidney Safety - Cisplatin
- Status last verified
- Jul 2014
- First submitted
- 29 Aug 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT01936376
- Acronym / sponsor ID
- Kidney Safety - Cisplatin
- Conditions
- Head and Neck Cancer
- Keywords
- kidney safety, biomarkers, serum creatinine, BUN, cystic fibrosis, head and neck cancer, renal injury, drug induced acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Foundation for the National Institutes of HealthUniversity, hospital or other
- 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
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| head & neck cancer patients, cisplatin treatment | – | – |
| cancer patients, no cisplatin, no nephrotoxic agent | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients
Key inclusion criteria (10 listed)
- Males and females ≥ 18 years of age
- 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:
- Willingness and ability to comply with study procedures and study restrictions
- Ability to provide written informed consent
- Males and females ≥ 18 years of age
Key exclusion criteria (10 listed)
- 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
- Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
- Any major surgery (i.e. high risk of acute kidney injury) in the previous month
- Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
- Use of creatine supplements within 7 days prior to hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biomarker change from baseline
Time frame: up to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Sultana, MD contact
Abdulla Salahudeen, MD principal investigator
M.D. Anderson Cancer Center
Sushrut Waikar, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Foundation for the National Institutes of Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Sultana, MD (stefan.sultana@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarker change from baseline (time frame: up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.