- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04033965
Corellation of Mutations, TILs and Age in Breast Cancer
25. juli 2019 opdateret af: Manto Nikolaidi, Hellenic Cooperative Oncology Group
Tumor Mutational Patterns and Infiltrating Lymphocyte Density in Young and Old Patients With Breast Cancer
Age may pertain to different tumor genotype characteristics which may interfere with treatment efficacy and prognosis.
The investigators investigated the distribution and prognostic effect of mutations (mut) and tumor infiltrating lymphocyte (TILs) in young and elderly early breast cancer patients (pts).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
345
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
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
women with early breast cancer <35 years old or >65 years old
Beskrivelse
Inclusion Criteria:
- women with early breast cancer <35 years old or >65 years old
Exclusion Criteria:
- NA
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 |
|---|---|
|
women <35 with early breast cancer
|
|
|
women>65 years old with early breast cancer
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer.
Tidsramme: Up to 13 years
|
Up to 13 years
|
|
Assessment of the prevalence of gene mutations in women >65years old with early breast cancer.
Tidsramme: Up to 13 years
|
Up to 13 years
|
|
Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women <=35 years old with early breast cancer.
Tidsramme: Up to 13 years
|
Up to 13 years
|
|
Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women >65 years old with early breast cancer.
Tidsramme: Up to 13 years
|
Up to 13 years
|
|
Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women <=35 years old with early breast cancer
Tidsramme: Up to 13 years
|
Up to 13 years
|
|
Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women >65 years old with early breast cancer.
Tidsramme: Up to 13 years
|
Up to 13 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Adamantia Nikolaidi, MD, Oncology Department, MITERA 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.
Generelle publikationer
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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)
3. september 1997
Primær færdiggørelse (Faktiske)
1. oktober 2010
Studieafslutning (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først indsendt
16. juli 2019
Først indsendt, der opfyldte QC-kriterier
25. juli 2019
Først opslået (Faktiske)
26. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
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