Clinical trial NCT00731536: Observational Study on the Occurrence of Hepatosplenic T-cell Lymphoma in Patients of Netherlands
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatosplenic T-cell Lymphoma
Keywords: Hepatosplenic T-cell Lymphoma
Remicade
Infliximab
Dutch national database of pathology
PALGA
Autoimmune disease
Non-Hodgkin lymphoma
Lead sponsor: Centocor Ortho Biotech Services, L.L.C.
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hepatosplenic T-cell Lymphoma (HSTCL).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL)
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with HSTCL that are present in the population of The Netherlands
timeFrame: 1 year
measure: Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands
timeFrame: 1 year
measure: Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands prior to and after the availability of infliximab
timeFrame: 1 year
measure: Data collection for factors associated with the diagnosis of HSTCL
timeFrame: 1 year
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
city: Amsterdam Zuidoost
country: Netherlands
city: Amsterdam
country: Netherlands
city: Eindhoven
country: Netherlands
city: Groningen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Oss
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Winschoten
country: Netherlands
Study officials:
affiliation: Centocor Ortho Biotech Services, L.L.C.
name: Centocor Ortho Biotech Services, L.L.C. Clinical Trial
role: STUDY_DIRECTOR
References: