Observational Study on the Occurrence of Hepatosplenic T-cell Lymphoma in Patients of Netherlands

Study Overview
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Brief Summary
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The purpose of this study is to examine reports of the cancer called hepatosplenic T-cell lymphoma (HSTCL) in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief or PALGA) during the years 1995 to 2008.

Detailed Description
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This is a observational, retrospective (a study in which the participants are identified and then followed backward in time, for the outcome of the study) study. In this study review of all reports of possible cases of hepatosplenic T-cell lymphoma (HSTCL) that were identified within the PALGA database of pathology results for The Netherlands from 1995 to 2008. All patients whose information is contained within the PALGA database were prescribed treatments by a physician on the basis of usual clinical practice or may have received other treatments, including experimental drugs, while participating in an interventional clinical study. The identified data on each of the patients with reports of HSTCL will be collected from the pathologist(s) who prepared the report and from the physician(s) who treated the patient at the time of diagnosis.

Official Title
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A Retrospective Review of Reports of Hepatosplenic T-cell Lymphoma in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief [PALGA]), a Database of Pathology Results for The Netherlands

Conditions
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Hepatosplenic T-cell Lymphoma

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients diagnosed with HSTCL in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief) database during the years 1995 to 2008 Exclusion Criteria: - Patients who are not diagnosed with HSTCL
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Hepatosplenic T-cell Lymphoma (HSTCL)<br> | Other: No intervention<br>* This is an observational study. Medical records of patients with the diagnosis of HSTCL in the PALGA database will be analyzed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL) | Evaluation of the occurrence of the diagnosis of HSTCL among patients with pathology reports in the Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA) database during the years 1995 to 2008. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with HSTCL that are present in the population of The Netherlands | Number of cases with HSTCL will be used to evaluate the prevalence. | 1 year | 
| Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands | Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL. | 1 year | 
| Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands prior to and after the availability of infliximab | Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL prior to and after the availability of infliximab. | 1 year | 
| Data collection for factors associated with the diagnosis of HSTCL | Data collection will include HSCTL diagnosis, diseases and medical/surgical conditions, cytogenetic data, and demographic data. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatosplenic T-cell Lymphoma, Remicade, Infliximab, Dutch national database of pathology, PALGA, Autoimmune disease, Non-Hodgkin lymphoma