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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00731536
First received: August 7, 2008
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hepatosplenic T-cell Lymphoma
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Centocor Ortho Biotech Services, L.L.C.:

Primary Outcome Measures:
  • Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of patients with HSTCL that are present in the population of The Netherlands [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number 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 Netherlands [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number 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 infliximab [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number 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 HSTCL [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Data collection will include HSCTL diagnosis, diseases and medical/surgical conditions, cytogenetic data, and demographic data.


Enrollment: 15
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Hepatosplenic T-cell Lymphoma (HSTCL).

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731536

Locations
Netherlands
Alkmaar, Netherlands
Amsterdam, Netherlands
Amsterdam Zuidoost, Netherlands
Eindhoven, Netherlands
Groningen, Netherlands
Nijmegen, Netherlands
Oss, Netherlands
Rotterdam, Netherlands
Utrecht, Netherlands
Winschoten, Netherlands
Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Investigators
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
  More Information

No publications provided

Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00731536     History of Changes
Other Study ID Numbers: CR015394, C0168Z06
Study First Received: August 7, 2008
Last Updated: October 14, 2013
Health Authority: United States: None due to the nature of the study (Registry)

Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Hepatosplenic T-cell Lymphoma
Remicade
Infliximab
Dutch national database of pathology
PALGA
Autoimmune disease
Non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 15, 2014