Lymphoma, T-Cell, Peripheral
Conditions
Keywords
Drug Therapy
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.
Interventions
OTHERNo Intervention
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification | 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 | 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 | 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. |
| Percentage of Participants with Each Subtypes of PTCL | Up to 6 months | Percentage of participants with each subtypes of PTCL according to the WHO 2008 classification of lymphoid neoplasms will be reported. |
| Classification of Peripheral T-cell Lymphoma | 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 | 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 | Up to 6 months | Distribution of the most frequent mutations in tumors and its correlation with clinical and phenotypic factors will be determined. |
| Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival | 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. |
Countries
Spain
Outcome results
None listed