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Clinical Trials/NCT00731536
NCT00731536CompletedNot Applicable

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

Centocor Ortho Biotech Services, L.L.C.0 sites15 target enrollmentStarted: October 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
15
Primary Endpoint
Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL)

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Data collection for factors associated with the diagnosis 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(1 year)
  • Number of patients with HSTCL that are present in the population of The Netherlands(1 year)
  • Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands(1 year)

Investigators

Sponsor
Centocor Ortho Biotech Services, L.L.C.
Sponsor Class
Industry
Responsible Party
Sponsor

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