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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: April 2010

Detailed Description

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.

Interventions

  • Other: No intervention
    • This is an observational study. Medical records of patients with the diagnosis of HSTCL in the PALGA database will be analyzed.

Arms, Groups and Cohorts

  • Patients with Hepatosplenic T-cell Lymphoma (HSTCL)

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL)
    • Time Frame: 1 year
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centocor Ortho Biotech Services, L.L.C.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Centocor Ortho Biotech Services, L.L.C. Clinical Trial, Study Director, Centocor Ortho Biotech Services, L.L.C.

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