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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731536
First Posted: August 11, 2008
Last Update Posted: October 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731536


Locations
Netherlands
Alkmaar, Netherlands
Amsterdam Zuidoost, Netherlands
Amsterdam, 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

Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00731536     History of Changes
Other Study ID Numbers: CR015394
C0168Z06 ( Other Identifier: Centocor, Inc. )
First Submitted: August 7, 2008
First Posted: August 11, 2008
Last Update Posted: October 16, 2013
Last Verified: October 2013

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