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

Completed

• Conditions: Lymphoma, T-Cell, Peripheral
• Interventions: Other: No Intervention

• Registration Number: NCT02788916
• Lead Sponsor: Takeda

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.

Study Timeline

• Study Start: 2015-09-25
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-02
• Primary Completion: 2016-11-10
• Study Completion: 2017-01-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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-

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Exclusion Criteria

• Participants with an unavailable history (lost, empty or not recoverable).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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 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.
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.