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Investigation of Cisplatin-Related Kidney Toxicity

10. september 2018 opdateret af: University of Chicago

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

102

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago

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

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients receiving anti-cancer treatment with cisplatin (or previously treated with cisplatin) at a participating academic medical center.

Beskrivelse

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.

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
Intervention / Behandling
Prospecitive Analysis
Patients currently receiving cisplatin as treatment for their cancer.
Andet: urine samples (biomarkers)
Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
Andet: blood samples (biomarkers)
blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
Andet: blood sample (DNA)
Blood sample collected for DNA analysis at anytime while on-study.
Restrospective Analysis
Patients that have previously received cisplatin as treatment for their cancer.
Andet: blood sample (DNA)
Blood sample collected for DNA analysis at anytime while on-study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in urine biomarker (NGAL) after cisplatin
Tidsramme: while on drug and up to 35 days after end of treatment
while on drug and up to 35 days after end of treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Change in blood and urine cystatin C
Tidsramme: while on drug and up to 35 days after end of treatment
while on drug and up to 35 days after end of treatment
Change in blood NGAL while receiving cisplatin
Tidsramme: while on drug and up to 35 days after end of treatment
while on drug and up to 35 days after end of treatment
Genetic markers of kidney toxicity
Tidsramme: while on drug and up to 35 days after end of treatment
while on drug and up to 35 days after end of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Chicago

Samarbejdspartnere

National Institutes of Health (NIH)
American Society of Clinical Oncology

Efterforskere

  • Ledende efterforsker: Peter H O'Donnell, MD, University of Chicago

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 (Faktiske)

22. september 2009

Primær færdiggørelse (Faktiske)

1. marts 2018

Studieafslutning (Faktiske)

1. marts 2018

Datoer for studieregistrering

Først indsendt

22. september 2009

Først indsendt, der opfyldte QC-kriterier

23. september 2009

Først opslået (Skøn)

24. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 09-135-B

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 .

Kliniske forsøg med urine samples (biomarkers)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Hong Kong

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner