- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01254318
Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501) (TRAFIC)
13. september 2016 opdateret af: Merck Sharp & Dohme LLC
Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)
This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada.
The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants.
The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
130
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Participants at high risk for IFI at medical institutions in Canada
Beskrivelse
Inclusion Criteria:
- To be eligible for study inclusion, the participant must have:
- A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant
Exclusion Criteria:
- The participant is not eligible for study inclusion if:
- Their IFI is not related to hematological malignancies.
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 |
---|---|
Participants at high risk for IFI
Participants will be considered high risk if they are undergoing high dose chemotherapy for leukemia.
This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.
Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation.
|
Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution
Tidsramme: 365 days
|
Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.
|
365 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution
Tidsramme: 365 days
|
Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.
|
365 days
|
Percentage of Participants With Invasive Fungal Infections in Canada
Tidsramme: 365 days
|
Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.
|
365 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. marts 2013
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
5. november 2010
Først indsendt, der opfyldte QC-kriterier
3. december 2010
Først opslået (Skøn)
6. december 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. september 2016
Sidst verificeret
1. september 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P07501
- MK-5592-071 (Anden identifikator: Merck Protocol Number)
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 .
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