- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01551251
Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer
27. juli 2015 opdateret af: Chung Fu-Tsai, Chang Gung Memorial Hospital
Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.
The purpose of this study is to investigate the effects of tumor associated macrophage (TAM) in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome of these subjects.
Pathologic specimens from tissue bank will be stained by immunostaining methods with CD68 antibody.
The clinical treatment response and outcomes will be analyzed between high or low TAM.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
107
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan, 10507
- Chang Gung Memorial Hospital
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Taoyuan, Taiwan
- Sant Paul Hospital
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All patients with advanced non-small cell lung cancer (stage IIIb and IV NSCLC) who had been treated at the Linkou Branch of Chang Gung Memorial Hospital between 2006 and 2009 were included.
Beskrivelse
Inclusion Criteria:
- advanced NSCLC,
- more than 20 years old,
- measurable tumor,
- response and outcome recorded after the first line treatment.
Exclusion Criteria:
- Early stage NSCLC,
- less than 20 years,
- pregnancy,
- unmeasurable NSCLC.
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 |
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Advanced NSCLC with high TAM
All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included.
Tumor specimens with high TAM were included as one cohort group.
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Advanced NSCLC with low TAM
All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included.
Tumor specimens with low TAM were included as one cohort group.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Response to treatment of advanced NSCLC with high or low TAM.
Tidsramme: 2-3 months
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All patients with advanced non-small cell lung cancer (NSCLC) who had been treated were included.
The decision of advanced NSCLC treatment was a consensus by the patient and clinician, and approved by team conference (including the oncologists, pulmonologists, pathologists, radiologists, surgeons, radiation oncologists, and nuclear medicine specialists).
The tumor response was evaluated using computerized tomography according to the Response Evaluation Criteria in Solid Tumors (RECIST).
The treatment response of advanced between high and low TAM patients were compared.
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2-3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Outcomes of advanced NSCLC with high and low TAM.
Tidsramme: 12-24 months
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The outcomes of advanced NSCLC with high and low TAM will be compared.
The outcomes include overall survival (OS) and progression-free survival (PFS).
Survival curves were estimated by the Kaplan-Meier method while the log-rank test was used to compare the patient survival times per groups.
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12-24 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Fu-Tsai Chung, M.D., Chang Gung Memorial Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. januar 2006
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
8. marts 2012
Først indsendt, der opfyldte QC-kriterier
9. marts 2012
Først opslået (Skøn)
12. marts 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2015
Sidst verificeret
1. april 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 100-0522B
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 .