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 ]
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