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

Study Overview
=================
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 Description
-----------------
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.

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

Conditions
-----------------
Lymphoma, T-Cell, Peripheral

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>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. | Other: No Intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy