Clinical trial NCT02788916: A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas
Official title: A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas in the Spanish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, T-Cell, Peripheral
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percentage of Participants with Each Subtypes of PTCL
timeFrame: Up to 6 months
measure: Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification
timeFrame: Up to 6 months
measure: Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL
timeFrame: Up to 6 months
measure: Correlation Between the Expression of CD30 and Lymphoid Lineage
timeFrame: Up to 6 months
measure: Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival
timeFrame: Up to 6 months
measure: Classification of Peripheral T-cell Lymphoma
timeFrame: Up to 6 months
measure: T-cell Clonality in PTCL
timeFrame: Up to 6 months
measure: Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
state: A Coruna
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Salamanca
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: