A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
23. januar 2015 opdateret af: Foundation for the National Institutes of Health
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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
150
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Dana-Farber Cancer Institute
-
Kontakt:
- Research Coordinator1
-
Kontakt:
- Research Coordinator2
-
Ledende efterforsker:
- Robert Haddad, MD
-
Boston, Massachusetts, Forenede Stater, 02115
- Ikke rekrutterer endnu
- Harvard Medical School - Brigham and Women's Hospital
-
Kontakt:
- Research Coordinator1
-
Kontakt:
- Research Coordinator2
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- University of Texas MD Anderson
-
Kontakt:
- Research Coordinator1
-
Kontakt:
- Research Coordinator2
-
Ledende efterforsker:
- Bonnie Glisson, MD
-
Underforsker:
- Ala Abudayyeh, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
cancer patients
Beskrivelse
Inclusion Criteria (Cisplatin Treatment Group):
- 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
Inclusion Criteria (Control Group):
- 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
Exclusion Criteria (All Subjects):
- 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
- Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)
- Significant anemia (Hemoglobin < 10 g/dL)
- Pregnancy
- Institutionalized individuals
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
head & neck cancer patients, cisplatin treatment
|
|
cancer patients, no cisplatin, no nephrotoxic agent
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
biomarker change from baseline
Tidsramme: up to 3 weeks
|
up to 3 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Abdulla Salahudeen, MD, University of Texas MD Anderson
- Ledende efterforsker: Sushrut Waikar, MD, Dana-Farber Cancer Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2012
Primær færdiggørelse (Forventet)
1. juni 2015
Studieafslutning (Forventet)
1. juni 2015
Datoer for studieregistrering
Først indsendt
29. august 2013
Først indsendt, der opfyldte QC-kriterier
3. september 2013
Først opslået (Skøn)
6. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. januar 2015
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Kidney Safety - Cisplatin
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .