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A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas

17. marts 2017 opdateret af: Takeda

A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas in the Spanish Population

The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a retrospective, non-interventional and, post-authorization observational study of other designs (PAS-OD).

This multicenter trial will be conducted in Spain. Retrospective review of medical records and initial tumor biopsies of participants diagnosed with PTCL in the period of 6 years between 01/01/2008 and 31/12/2013 will be performed. Initial tumor biopsies and histological preparations, filed and previously anonymized, will be sent to the central laboratory for assessment.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

198

Kontakter og lokationer

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

Studiesteder

  • Spanien
      • Barcelona, Spanien
      • Cordoba, Spanien
      • Madrid, Spanien
      • Oviedo, Spanien
      • Salamanca, Spanien
      • Santander, Spanien
      • Sevilla, Spanien
      • Valencia, Spanien
    • A Coruna
      • Santiago de Compostela, A Coruna, Spanien
    • Madrid
      • Majadahonda, Madrid, Spanien

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

Sandsynlighedsprøve

Studiebefolkning

Participants diagnosed with PTCL in the six years between 01 January 2008 and 31 December 2013 in the participating sites.

Beskrivelse

Inclusion Criteria:

  • Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013.
  • Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).

  • PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:

    • Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type
    • Enteropathic T-cell lymphoma
    • Hepatosplenic T-cell lymphoma
    • Peripheral T-cell lymphoma, not otherwise specified
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+
    • Anaplastic large cell lymphoma, ALK-

Exclusion Criteria:

• Participants with an unavailable history (lost, empty or not recoverable).

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
Cohort 1
Assessment of tumor biopsies and histological preparations of participants diagnosed with peripheral T-cell lymphoma (PTCL) in the six years between 01 January 2008 and 31 December 2013 will be performed.
Andet: Ingen indgriben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes
Tidsramme: Up to 6 months
Distribution of PTCL subtypes by re-analysis and re-classification of samples according to the 2008 WHO classification of lymphoid neoplasms will be estimated.
Up to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants with Each Subtypes of PTCL
Tidsramme: Up to 6 months
Percentage of participants with each subtypes of PTCL according to the WHO 2008 classification of lymphoid neoplasms will be reported.
Up to 6 months
Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification
Tidsramme: Up to 6 months
Rate of discrepancy between the initial diagnosis of PTCL in participants and diagnosis by re-analysis and re-classification according to the WHO 2008 classification will be determined.
Up to 6 months
Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL
Tidsramme: Up to 6 months
Expression of CD30 by immunohistochemistry and quantitative RT-PCR in different subtypes of PTCL will be determined.
Up to 6 months
Correlation Between the Expression of CD30 and Lymphoid Lineage
Tidsramme: Up to 6 months
Markers of T and B cells will be used in order to determine if CD30 expression occurs in tumor cells or other B-lineage.
Up to 6 months
Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival
Tidsramme: Up to 6 months
Survival includes progression free survival: period from date of start of treatment until tumor progression or death, whichever occurs first. Overall survival: period from date of diagnosis to the date of death.
Up to 6 months
Classification of Peripheral T-cell Lymphoma
Tidsramme: Up to 6 months
The PTCL is classified according to the expression of CD30 and T-Cell Receptor ß (TCRß) and T-Cell Receptor γ (TCRγ) by immunohistochemistry (IHC).
Up to 6 months
T-cell Clonality in PTCL
Tidsramme: Up to 6 months
Analysis of T-cell clonality in PTCL will be performed. Clonality defines the profile of gene rearrangement of T cell receptor and allow establishing whether proliferation is monoclonal.
Up to 6 months
Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors
Tidsramme: Up to 6 months
Distribution of the most frequent mutations in tumors and its correlation with clinical and phenotypic factors will be determined.
Up to 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Takeda

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)

25. september 2015

Primær færdiggørelse (Faktiske)

10. november 2016

Studieafslutning (Faktiske)

12. januar 2017

Datoer for studieregistrering

Først indsendt

23. maj 2016

Først indsendt, der opfyldte QC-kriterier

26. maj 2016

Først opslået (Skøn)

2. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Brentuximab-5012
  • TAK-HEM-2015-01 (Registry Identifier: AEMPS)

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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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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