Corellation of Mutations, TILs and Age in Breast Cancer
25. juli 2019 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
345
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
women <35 with early breast cancer
|
|
|
women>65 years old with early breast cancer
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Adamantia Nikolaidi, MD, Oncology Department, MITERA Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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- Kotoula V, Chatzopoulos K, Lakis S, Alexopoulou Z, Timotheadou E, Zagouri F, Pentheroudakis G, Gogas H, Galani E, Efstratiou I, Zaramboukas T, Koutras A, Aravantinos G, Samantas E, Psyrri A, Kourea H, Bobos M, Papakostas P, Kosmidis P, Pectasides D, Fountzilas G. Tumors with high-density tumor infiltrating lymphocytes constitute a favorable entity in breast cancer: a pooled analysis of four prospective adjuvant trials. Oncotarget. 2016 Jan 26;7(4):5074-87. doi: 10.18632/oncotarget.6231.
- Kotoula V, Lyberopoulou A, Papadopoulou K, Charalambous E, Alexopoulou Z, Gakou C, Lakis S, Tsolaki E, Lilakos K, Fountzilas G. Evaluation of two highly-multiplexed custom panels for massively parallel semiconductor sequencing on paraffin DNA. PLoS One. 2015 Jun 3;10(6):e0128818. doi: 10.1371/journal.pone.0128818. eCollection 2015.
- Sun H, Yu G. New insights into the pathogenicity of non-synonymous variants through multi-level analysis. Sci Rep. 2019 Feb 7;9(1):1667. doi: 10.1038/s41598-018-38189-9.
- Martincorena I, Raine KM, Gerstung M, Dawson KJ, Haase K, Van Loo P, Davies H, Stratton MR, Campbell PJ. Universal Patterns of Selection in Cancer and Somatic Tissues. Cell. 2017 Nov 16;171(5):1029-1041.e21. doi: 10.1016/j.cell.2017.09.042. Epub 2017 Oct 19. Erratum In: Cell. 2018 Jun 14;173(7):1823.
- Poggio F, Lambertini M, Bighin C, Conte B, Blondeaux E, D'Alonzo A, Dellepiane C, Boccardo F, Del Mastro L. Management of young women with early breast cancer. ESMO Open. 2018 Nov 14;3(Suppl 1):e000458. doi: 10.1136/esmoopen-2018-000458. eCollection 2018.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. september 1997
Primær fullføring (Faktiske)
1. oktober 2010
Studiet fullført (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først innsendt
16. juli 2019
Først innsendt som oppfylte QC-kriteriene
25. juli 2019
Først lagt ut (Faktiske)
26. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HE10/mut
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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