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

Takeda

Status: Completed

Conditions: Lymphoma, T-Cell, Peripheral

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02788916

Brentuximab-5012

TAK-HEM-2015-01 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

198 participants in 1 patient group

Cohort 1

Description:

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.

Treatment:

Other: No Intervention