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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00731536
Enrollment
15
Registered
2008-08-11
Start date
2008-10-31
Completion date
2010-04-30
Last updated
2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatosplenic T-cell Lymphoma

Keywords

Hepatosplenic T-cell Lymphoma, Remicade, Infliximab, Dutch national database of pathology, PALGA, Autoimmune disease, Non-Hodgkin lymphoma

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.

Interventions

OTHERNo intervention

This is an observational study. Medical records of patients with the diagnosis of HSTCL in the PALGA database will be analyzed.

Sponsors

Centocor Ortho Biotech Services, L.L.C.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL)1 yearEvaluation 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

MeasureTime frameDescription
Number of patients with HSTCL that are present in the population of The Netherlands1 yearNumber 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 Netherlands1 yearNumber 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 infliximab1 yearNumber 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 HSTCL1 yearData collection will include HSCTL diagnosis, diseases and medical/surgical conditions, cytogenetic data, and demographic data.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026