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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatosplenic T-cell Lymphoma
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Netherlands
  • Alkmaar, Netherlands
  • Amsterdam, Netherlands
  • Amsterdam Zuidoost, Netherlands
  • Eindhoven, Netherlands
  • Groningen, Netherlands
  • Nijmegen, Netherlands
  • Oss, Netherlands
  • Rotterdam, Netherlands
  • Utrecht, Netherlands
  • Winschoten, Netherlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Hepatosplenic T-cell Lymphoma (HSTCL).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centocor Ortho Biotech Services, L.L.C.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 11, 2008

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 14, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Infliximab; Remicade; Non-Hodgkin lymphoma; Autoimmune disease; Hepatosplenic T-cell Lymphoma; Dutch national database of pathology; PALGA
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: CR015394; C0168Z06 (Other Identifier: Centocor, Inc.)