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

Hepatosplenic T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731536
• Other study ID #: CR015394
• Secondary ID: C0168Z06
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2008
• Last updated: October 14, 2013
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: October 2013
• Source: Centocor Ortho Biotech Services, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None due to the nature of the study (Registry)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatosplenic T-cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor Ortho Biotech Services, L.L.C.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No