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.
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.
Study Type
OBSERVATIONAL
Enrollment
198
Unnamed facility
Santiago de Compostela, A Coruna, Spain
Unnamed facility
Barcelona, Barcelona, Spain
Unnamed facility
Santander, Cantabria, Spain
Unnamed facility
Córdoba, Cordoba, Spain
Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes
Distribution of PTCL subtypes by re-analysis and re-classification of samples according to the 2008 WHO classification of lymphoid neoplasms will be estimated.
Time frame: Up to 6 months
Percentage of Participants with Each Subtypes of PTCL
Percentage of participants with each subtypes of PTCL according to the WHO 2008 classification of lymphoid neoplasms will be reported.
Time frame: Up to 6 months
Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification
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.
Time frame: 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
Expression of CD30 by immunohistochemistry and quantitative RT-PCR in different subtypes of PTCL will be determined.
Time frame: Up to 6 months
Correlation Between the Expression of CD30 and Lymphoid Lineage
Markers of T and B cells will be used in order to determine if CD30 expression occurs in tumor cells or other B-lineage.
Time frame: Up to 6 months
Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival
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.
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Unnamed facility
Madrid, Madrid, Spain
Unnamed facility
Majadahonda, Madrid, Spain
Unnamed facility
Oviedo, Oviedo, Spain
Unnamed facility
Salamanca, Salamanca, Spain
Unnamed facility
Seville, Sevilla, Spain
Unnamed facility
Valencia, Valencia, Spain
Time frame: Up to 6 months
Classification of Peripheral T-cell Lymphoma
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).
Time frame: Up to 6 months
T-cell Clonality in PTCL
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.
Time frame: Up to 6 months
Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors
Distribution of the most frequent mutations in tumors and its correlation with clinical and phenotypic factors will be determined.
Time frame: Up to 6 months