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NCT Number: NCT02788916

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

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.

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Key information

Conditions

Lymphoma, T-Cell, Peripheral Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Observational

Primary location

Santiago de Compostela, A Coruna, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes

    Time frame: 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 2, 2016
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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