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

NCT ID: NCT02788916

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-25

Study Completion Date

2017-01-12

Brief Summary

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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

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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.

Conditions

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Lymphoma, T-Cell, Peripheral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

Interventions

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No Intervention

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

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Santiago de Compostela, A Coruna, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Santander, Cantabria, Spain

Site Status

Córdoba, Cordoba, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Majadahonda, Madrid, Spain

Site Status

Oviedo, Oviedo, Spain

Site Status

Salamanca, Salamanca, Spain

Site Status

Seville, Sevilla, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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TAK-HEM-2015-01

Identifier Type: REGISTRY

Identifier Source: secondary_id

Brentuximab-5012

Identifier Type: -

Identifier Source: org_study_id

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