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Completed

NCT Number: NCT00731536

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

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Key information

Conditions

Hepatosplenic T-cell Lymphoma Autoimmune Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Observational

Primary location

Alkmaar, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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

  1. Number of patients with HSTCL that are present in the population of The Netherlands

    Time frame: 1 year

    Number of cases with HSTCL will be used to evaluate the prevalence.

  2. Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands

    Time frame: 1 year

    Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL.

  3. Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands prior to and after the availability of infliximab

    Time frame: 1 year

    Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL prior to and after the availability of infliximab.

  4. Data collection for factors associated with the diagnosis of HSTCL

    Time frame: 1 year

    Data collection will include HSCTL diagnosis, diseases and medical/surgical conditions, cytogenetic data, and demographic data.

Sponsors and collaborators

Lead sponsor

Centocor Ortho Biotech Services, L.L.C.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2008
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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