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

Lymphoma, T-Cell, Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788916
• Other study ID #: Brentuximab-5012
• Secondary ID: TAK-HEM-2015-01
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: March 17, 2017
• Start date: September 25, 2015
• Est. completion date: January 12, 2017

Study information

• Verified date: March 2017
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 12, 2017
• Est. primary completion date: November 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

Intervention

Other:
• No Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 ? (TCR?) by immunohistochemistry (IHC).	Up to 6 months
Secondary	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
Secondary	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