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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Takeda

Current Primary Outcome: Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of Participants with Each Subtypes of PTCL [ Time Frame: Up to 6 months ]
    Percentage of participants with each subtypes of PTCL according to the WHO 2008 classification of lymphoid neoplasms will be reported.
  • Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification [ Time Frame: 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.
  • Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL [ Time Frame: Up to 6 months ]
    Expression of CD30 by immunohistochemistry and quantitative RT-PCR in different subtypes of PTCL will be determined.
  • Correlation Between the Expression of CD30 and Lymphoid Lineage [ Time Frame: 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.
  • Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival [ Time Frame: 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.
  • Classification of Peripheral T-cell Lymphoma [ Time Frame: 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).
  • T-cell Clonality in PTCL [ Time Frame: 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.
  • Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors [ Time Frame: Up to 6 months ]
    Distribution of the most frequent mutations in tumors and its correlation with clinical and phenotypic factors will be determined.


Original Secondary Outcome:

  • Percentage of Participants with Each Subtypes of PTCL [ Time Frame: Up to 6 months ]
    Percentage of participants with each subtypes of PTCL according to the WHO 2008 classification of lymphoid neoplasms will be reported.
  • Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification [ Time Frame: 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.
  • Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL [ Time Frame: Up to 6 months ]
    Expression of CD30 by immunohistochemistry and quantitative RT-PCR in different subtypes of PTCL will be determined.
  • Correlation Between the Expression of CD30 and Lymphoid Lineage [ Time Frame: 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.
  • Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival [ Time Frame: 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.
  • Classification of Peripheral T-cell Lymphoma [ Time Frame: 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).
  • T-cell Clonality in PTCL [ Time Frame: 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.
  • Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors [ Time Frame: Up to 6 months ]


Information By: Takeda

Dates:
Date Received: May 23, 2016
Date Started: September 25, 2015
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017