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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, T-Cell, Peripheral
• Intervention / Treatment: Other: No Intervention

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 Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
  • Cordoba, Spain
  • Madrid, Spain
  • Oviedo, Spain
  • Salamanca, Spain
  • Santander, Spain
  • Sevilla, Spain
  • Valencia, Spain
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain
  • Madrid
    • Majadahonda, Madrid, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants diagnosed with PTCL in the six years between 01 January 2008 and 31 December 2013 in the participating sites.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; 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

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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2015
• Primary Completion (Actual): November 10, 2016
• Study Completion (Actual): January 12, 2017

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: Brentuximab-5012; TAK-HEM-2015-01 (Registry Identifier: AEMPS)