Observational Study on the Occurrence of Hepatosplenic T-cell Lymphoma in Patients of Netherlands
October 14, 2013 updated by: Centocor Ortho Biotech Services, L.L.C.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Amsterdam Zuidoost, Netherlands
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Eindhoven, Netherlands
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Groningen, Netherlands
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Nijmegen, Netherlands
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Oss, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Winschoten, Netherlands
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Hepatosplenic T-cell Lymphoma (HSTCL).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with Hepatosplenic T-cell Lymphoma (HSTCL)
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This is an observational study.
Medical records of patients with the diagnosis of HSTCL in the PALGA database will be analyzed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL)
Time Frame: 1 year
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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.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with HSTCL that are present in the population of The Netherlands
Time Frame: 1 year
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Number of cases with HSTCL will be used to evaluate the prevalence.
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1 year
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Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands
Time Frame: 1 year
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Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL.
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1 year
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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
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Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL prior to and after the availability of infliximab.
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1 year
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Data collection for factors associated with the diagnosis of HSTCL
Time Frame: 1 year
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Data collection will include HSCTL diagnosis, diseases and medical/surgical conditions, cytogenetic data, and demographic data.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
August 7, 2008
First Submitted That Met QC Criteria
August 7, 2008
First Posted (Estimate)
August 11, 2008
Study Record Updates
Last Update Posted (Estimate)
October 16, 2013
Last Update Submitted That Met QC Criteria
October 14, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015394
- C0168Z06 (Other Identifier: Centocor, Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.